MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-04-25 for ANGEL? CATHETER 2012-0527 N/A manufactured by Bio2 Medical Inc.
[106589250]
This event was received through a published case report (see below), and all follow-up inquiries regarding the return or identification of the device did not receive a response. Without access to the device involved or lot number identification, the device event could not be fully investigated. Review of the specific dhr for this device was not performed as the lot number is unknown. The case report alleges that a pre-removal imaging of the device demonstrated a partial fracture of the filter. The device reportedly performed as intended during the indwelling period (22 days). The report stated that the patient was disoriented and confused with episodes of severe agitation during the intensive care unit stay. In addition, the patient underwent surgical fixation of multiple lower limb fractures during the indwelling period. It is not known whether the reported patient agitation or surgical procedures during the indwelling period contributed to the partial fracture observed at pre-removal. The angel? Catheter was successfully retrieved, and a final venogram demonstrated no residual thrombus or vessel injury. The patient's post-retrieval recovery was reported as uneventful. Filter fractures are a recognized complication for ivc filters. As stated in the following warnings 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. As the device could not be fully investigated, the root cause of the reported partial filter fracture is inconclusive based on the available information. Bio2 medical will continue to monitor and trend this failure mode. Case report: "broken wings: first reported cases of fractured angel? Catheter, a temporary combined femoral venous catheter and retrievable ivc filter device", published in the journal of cardiovascular interventional radiology on march 14, 2018.
Patient Sequence No: 1, Text Type: N, H10
[106589251]
Patient transferred to interventional radiology department for angel? Catheter retrieval twenty-two (22) days post-insertion. Pre-removal imaging demonstrated partial fracture of the filter component. Surgical procedure was required for removal of the filter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009903437-2018-00001 |
| MDR Report Key | 7463456 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-25 |
| Date Mfgr Received | 2018-03-26 |
| Date Added to Maude | 2018-04-25 |
| 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 | 2018-04-25 |
| Model Number | 2012-0527 |
| Catalog Number | N/A |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-04-25 |