MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-21 for ANGEL? CATHETER AC3930A manufactured by Bio2 Medical, Inc..
[73449631]
An incident of a fractured filter was reported on (b)(6) 2017. The device was indwelling for 3 days in a patient with multiple bone fractures. In pre-removal cavagram imaging performed on (b)(6) 2017, the filter appeared intact with no clot burden. During an attempt to retrieve the filter into the sheath, it would not collapse. After repeated attempts, a surgical procedure was performed where a large sheath was inserted and grasping forceps were used to position the filter into the sheath. Multiple wires on the filter struts were fractured; metal shards were removed. A ct was completed and was negative for any foreign bodies. Following the procedure, the patient was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
[96237077]
The customer refused to return the incident device or provide imaging of the device for evaluation. However, bio2 medical personnel were permitted to visually examine and photograph the retained portion of the incident device during an onsite visit, but were not permitted to touch the device in any way or to test or check the parameters of the device. Visual examination revealed that only a portion of the incident device had been retained. It was confirmed that no additional imaging or procedural information would be provided to bio2 medical support a thorough root cause investigation. The visual condition of the device components is consistent with the removal procedure described above. A thorough internal review of the manufacturing documentation for this lot number (062116-408) demonstrated that the device met all manufacturing specification requirements of the bio2 medical quality system prior to its production release. It cannot be confirmed (based solely on an examination of photographs of the removed device components) when or where the filter experienced the initial fracture. As the device could not be fully investigated, the root cause of the reported filter fracture or relationship (if any) of the device to the reported incident cannot be determined. Bio2 medical will reopen this investigation if additional information pertinent to the incident is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009903437-2017-00001 |
| MDR Report Key | 6513424 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-21 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2016-06-21 |
| Date Added to Maude | 2017-04-21 |
| 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 | 2017-04-21 |
| Model Number | NA |
| Catalog Number | AC3930A |
| Lot Number | 062116-408 |
| Device Expiration Date | 2018-06-21 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-04-21 |