MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-01-11 for ANGEL? CATHETER 2012-0527 N/A manufactured by Bio2 Medical Inc.
[64576338]
(b)(4). This event involved our ce marked device, and occurred outside the u. S. (ous). The design of the ce marked angel? Catheter (part no. 2012-0527) is identical to the 510(k) cleared angel? Catheter (catalog no. Ac3930a), despite differences in luer pad printing, labeling, instructions for use, part number, catalog number, indications, and approved uses.
Patient Sequence No: 1, Text Type: N, H10
[64576339]
The incident was diagnosed during the pre-removal cavogram imaging performed on (b)(6) 2016. A gentleman was admitted to the hospital with severe facial fractures which required multiple trips to theatre. The patient had a previous history of a number of dvts and pes. The clinical team in radiology placed an angel catheter to provide cover for his surgery. The catheter remained in place for ~2. 5 weeks during which time he had reasonably vigorous physiotherapy. Once all the operations were completed, the catheter was listed for removal. The venogram demonstrated that a number of struts on the filter (at least 2) had fractured and it would not easily collapse down into the sheath. Another sheath was placed from the jugular approach, above the angel catheter filter, to capture the top part of the filter while simultaneously attempting to sheath the inferior margin & lower half of the filter using the angel catheter sheath. Then, the physicians moved everything down into the common femoral and attempted to retrieve both parts of the filter. As a result, the top part of the filter further unraveled. This eventually led to further surgery and a cut down onto the common femoral vein to remove the angel catheter.
Patient Sequence No: 1, Text Type: D, B5
[65475579]
The initial report was delayed for a number of reasons. (b)(4). This event involved our ce marked device, and occurred outside the u. S. (ous). The design of the ce marked angel catheter (part no. 2012-0527) is identical to the 510(k) cleared angel catheter (catalog no. Ac3930a), despite differences in luer pad printing, labeling, instructions for use, part number, catalog number, indications, and approved uses.
Patient Sequence No: 1, Text Type: N, H10
[65475580]
The incident was diagnosed during the pre-removal cavogram imaging performed on (b)(6) 2016. A gentleman was admitted to the hospital with severe facial fractures which required multiple trips to theatre. The patient also had a previous history of a number of dvts and pes. The clinical team in radiology placed an angel catheter to provide cover for his surgery. The catheter remained in place for ~2. 5 weeks during which time he had reasonably vigorous physiotherapy. Once all the operations were completed, the catheter was listed for removal. The venogram demonstrated that a number of struts on the filter (at least 2) had fractured and it would not easily collapse down into the sheath. Another sheath was placed from the jugular approach, above the angel catheter filter, to capture the top part of the filter while simultaneously attempting to sheath the inferior margin & lower half of the filter using the angel catheter sheath. Then, the physicians moved everything down into the common femoral and attempted to retrieve both parts of the filter. As a result, the top part of the filter further unravelled. This eventually led to further surgery and a cut down onto the common femoral vein to remove the angel catheter. Upon subsequent review of the patient's placement kub, the reporting physician believes that at least 1 strut of the angel catheter filter was fractured at the time of placement. It was further hypothesized by the physician that during the indwelling period the filter became partly endothelialised into the ivc wall, fixing it in place. Given that it was also fixed in the groin, this led to tension, causing the struts to further snap.
Patient Sequence No: 1, Text Type: D, B5
[65852188]
This event involved our ce marked device, and occurred outside the u. S. (ous). The design of the ce marked angel? Catheter (part no. 2012-0527) is identical to the 510(k) cleared angel? Catheter (catalog no. Ac3930a), despite differences in luer pad printing, labeling, instructions for use, part number, catalog number, indications, and approved uses. The relevant device history records have been reviewed. Specifically, the incoming inspection records for the filters used in the returned device lot (0141315-373, part no. 2012-0527) were reviewed for non-conformities which could possibly have contributed to such an event if used in clinical product. It was verified that the device met all requirements prior to release. Bio2 medical received the placement imaging (kub) as well as the pre-removal cavogram assessment and retrieval imaging. A portion of the device including approximately half of the multilumen tubing, the filter, and the distal tip were also received and inspected by bio2 medical. Bio2 medical's chief medical officer, another colleague from interventional radiology, and subsequently the bio2 medical's engineering team reviewed the placement kub imaging, and determined that the filter was centered in the vena cava, intact, and undamaged at the time of placement. It is suspected that during the indwelling period, a portion of the filter fractured and was incorporated into the caval wall (without penetration) due to endothelialization. It is impossible to determine which may have occurred first, the filter fracture or incorporation into the vessel wall, with the available information. The physician reported that this patient received vigorous physiotherapy during the catheter indwelling period. However, there was no documentation of device movement during the indwelling period. Further review of the pre-removal cavogram imaging and the device itself confirmed that there were three fractures at the time of the pre-removal cavogram. Additional, secondary fractures occurred during retrieval as a result of the methods used to collapse and ensnare the already fractured filter that was incorporated in the vessel wall. The physician cut through the angel(r) catheter outersheath and multilumen during the attempt to constrain the filter. The device had to be surgically removed as the fractured filter could not be successfully constrained. The patient was reported to have made a successful recovery and was discharged home on (b)(6) 2016. Filter fractures are a recognized complication for ivc filters. As stated in the angel catheter ifu (2013-0533), "filter fractures are a known complication of vena cava filters. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques. Retrieval of the filter with a filter fracture present may result in complications that require surgical intervention to remove the angel? Catheter. " however, it should be noted that this is the only event reported to date for this failure mode, lot number, and this device (the ce-marked angel(r) catheter, part no. 2012-0527) as well as the similar, fda-cleared device (catalog no. Ac3930a). The root cause of this event is inconclusive based on the available information. Bio2 medical will continue to monitor and trend this failure mode.
Patient Sequence No: 1, Text Type: N, H10
[65852189]
The incident was diagnosed during the pre-removal cavogram imaging performed on (b)(6) 2016. A gentleman was admitted to the hospital with severe facial fractures which required multiple trips to theatre. The patient also had a previous history of a number of dvts and pes. The clinical team in radiology placed an angel catheter to provide cover for his surgery. The catheter remained in place for ~2. 5 weeks during which time he had reasonably vigorous physiotherapy. Once all the operations were completed, the catheter was listed for removal. The venogram demonstrated that a number of struts on the filter (at least 2) had fractured and it would not easily collapse down into the sheath. Another sheath was placed from the jugular approach, above the angel catheter filter, to capture the top part of the filter while simultaneously attempting to sheath the inferior margin and lower half of the filter using the angel catheter sheath. Then, the physicians moved the device down into the common femoral and attempted to retrieve both parts of the filter. As a result, the top part of the filter further unravelled. This eventually led to further surgery and a cut down onto the common femoral vein to remove the angel catheter. Upon subsequent review of the patient's placement kub, the reporting physician believes that at least 1 strut of the angel catheter filter was fractured at the time of placement. It was further hypothesized by the physician that during the indwelling period the filter became partly endothelialised into the ivc wall, fixing it in place. Given that the external part of the device was also fixed in the groin, this led to tension, causing the struts to further fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009903437-2016-00001 |
| MDR Report Key | 6243389 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-11 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-11-01 |
| Date Mfgr Received | 2016-11-14 |
| Device Manufacturer Date | 2015-04-13 |
| Date Added to Maude | 2017-01-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULIE ROSS |
| Manufacturer Street | 4670 TABLE MOUNTAIN DRIVE |
| Manufacturer City | GOLDEN CO 80403 |
| Manufacturer Country | US |
| Manufacturer Postal | 80403 |
| Manufacturer Phone | 7208335688 |
| Manufacturer G1 | BIO2 MEDICAL INC |
| Manufacturer Street | 4670 TABLE MOUNTAIN DRIVE |
| Manufacturer City | GOLDEN CO 80403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL? CATHETER |
| Generic Name | INFERIOR VENA CAVA FILTER AND CENTRAL VENOUS CATHETER |
| Product Code | PNS |
| Date Received | 2017-01-11 |
| Returned To Mfg | 2017-01-09 |
| Model Number | 2012-0527 |
| Catalog Number | N/A |
| Lot Number | 041315-373 |
| Device Expiration Date | 2017-04-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO2 MEDICAL INC |
| Manufacturer Address | 4670 TABLE MOUNTAIN DRIVE GOLDEN CO 80403 US 80403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-11 |