MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-06 for TUNNELER PVT0600 manufactured by Bard Peripheral Vascular, Inc..
[69130468]
Patient Sequence No: 1, Text Type: N, H10
[69130469]
Received dictation of a l common femoral artery to anterior tibial artery bypass by the dr. On this pt. In the findings the following was noted; "we had lost the head of the bullet to the tunneler during the procedure, we had to use x-ray and we were able to locate it. We made a small incision and retrieved the bullet as this had become unattached from the tunneler. Per notes, pt did well without further issue and was discharged home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6380041 |
| MDR Report Key | 6380041 |
| Date Received | 2017-03-06 |
| Date of Report | 2017-02-09 |
| Date of Event | 2016-05-03 |
| Report Date | 2017-02-09 |
| Date Reported to FDA | 2017-02-09 |
| Date Reported to Mfgr | 2017-02-09 |
| Date Added to Maude | 2017-03-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUNNELER |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MZY |
| Date Received | 2017-03-06 |
| Model Number | PVT0600 |
| Catalog Number | PVT0600 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Brand Name | TUNNELER |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2017-03-06 |
| Model Number | PVT0600 |
| Catalog Number | PVT0600 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-06 |