MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-05 for PV SHEATH TUNNELER PVT0600 manufactured by Bard Peripheral Vascular, Inc..
[72105206]
(b)(4). No medical images were provided to the manufacturer. As the lot number for the device was not provided, a review of the device history records will not be performed. The device is not available for return. The investigation is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[72105207]
It was reported that during treatment in a bypass procedure extending from the left common femoral artery to the anterior tibial artery, the bullet tip of the surgical tunneler allegedly detached and remained in the patient. It was further reported that the healthcare provider used an x-ray device, located the bullet tip, made a small incision in a second location, and removed the bullet tip without incident. The patient was hemodynamically stable at the conclusion of the procedure.
Patient Sequence No: 1, Text Type: D, B5
[75945995]
Event details received via medwatch (b)(4). Manufacturing review: a complete manufacturing review could not be performed as the lot number was not provided. Visual inspection: the sample was not returned; therefore, a visual inspection could not be performed. Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: the device was not returned for evaluation. Images and medical records were not provided for review. Therefore, the investigation is inconclusive for the alleged detachment of the bullet tip from the tunneler. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: using the tunneler: to assemble the sterile tunneler components: carefully secure (thread) the handle onto either end of the rod. Slide the rod through the sheath, so that the threaded end of the rod extends beyond the sheath end. Attach (thread) the bullet tip to the exposed end of the rod. Hand-tighten the assembly, making sure that the shoulders of the bullet tip and handle are snug against the ends of the sheath. Maintenance: proper maintenance of the pv sheath tunneler requires careful handling and inspection of each tunneler component and the tunneler sterilization cassette. Particular care should be taken to avoid damaging the threaded portions of the rod, handle, and bullet tip. If these areas are damaged through improper handling (i. E. , dropping, cross-threading, brushing and/or cleaning with abrasives) the parts may not fit together properly or be-interchangeable on the rod ends. Do not use the tunneler if such damage occurs. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[75945996]
It was reported that during treatment in a bypass procedure extending from the left common femoral artery to the anterior tibial artery, the bullet tip of the surgical tunneler allegedly detached and remained in the patient. It was further reported that the health care provider used an x-ray device, located the bullet tip, made a small incision in a second location, and removed the bullet tip without incident. The patient was hemodynamically stable at the conclusion of the procedure. New information received: it was reported that following failed endovascular management, the patient with a non-healing ulceration of the left great toe and rest pain presented for bypass of the highly calcific femoral artery. A cryovein was used to bypass from the common femoral artery, down to the anterior tibial artery. When the peripheral vascular tunneler passed through the exit incision, the tip of the tunneler was absent. X-ray performed identified the detached tip to be just above the knee and a counterincision was used to remove the tip. A triphasic completion arteriogram demonstrated good flow throughout. The patient was hemodynamically stable at the conclusion of the procedure. No additional medical records were received for this patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2017-00311 |
| MDR Report Key | 6462410 |
| Date Received | 2017-04-05 |
| Date of Report | 2017-05-15 |
| Date of Event | 2016-05-03 |
| Date Mfgr Received | 2017-05-02 |
| Date Added to Maude | 2017-04-05 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PV SHEATH TUNNELER |
| Generic Name | SURGICAL TUNNELER |
| Product Code | MZY |
| Date Received | 2017-04-05 |
| Catalog Number | PVT0600 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-04-05 |