MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-01-12 for EPTFE VASCULAR GRAFT UNKNOWN GRAFT manufactured by Bard Peripheral Vascular, Inc..
[64712936]
No medical records and no medical images were provided to the manufacturer. 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
[64712937]
It was reported that after an unknown amount of time post graft placement, the patient developed a pseudoaneurysm after a short time on hemodialysis. The current patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
[66369202]
Manufacturing review: a manufacturing review could not be performed, as the lot number was not provided. Visual/microscopic inspection: visual/microscopic inspection could not be performed as the device was not returned. Functional/performance evaluation: functional/performance evaluation could not be performed as the device was not returned. Medical records review: medical records were not provided. Image/photo review: no images or photos were provided. Conclusion: there was no specific deficiency alleged. The investigation was inconclusive. Based upon the available information, the definitive root cause was unknown. Labeling review: the current ifu (instructions for use) states: adverse reactions: potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: disruption or tearing of the suture line graft, and/or host vessel; suture hole bleeding; graft redundancy; thrombosis, embolic events, occlusion or stenosis; ultrafiltration; seroma formation; swelling of the implanted limb; formation of hematoma or pseudoaneurysm; infection; aneurysm/dilation; blood leakage; hemorrhage; steal syndrome; and/or skin erosion. Blood access procedures: leave the graft in place for approximately two weeks prior to use. There is an increased risk of hematoma formation if the graft is punctured prior to complete healing: insert the blood access needle at a 20? To 45? Angle, with the bevel up. When the graft is penetrated, advance the needle parallel to the graft; rotate (change) the cannulation sites; do not repeat cannulation in the same area. Repeat cannulation may lead to formation of a hematoma or a pseudoaneurysm. Do not cannulate within the dialysis needle? S length of the proximal and distal anastomosis; strictly adhere to aseptic technique to minimize infection; apply moderate digital pressure to the cannulation site after needle withdrawal. This compression assists in hemostasis. 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
[66369203]
It was reported that after an unknown amount of time post graft placement, the patient developed a pseudoaneurysm after a short time on hemodialysis. The current patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2017-00002 |
| MDR Report Key | 6248316 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-12 |
| Date of Report | 2016-12-15 |
| Date Mfgr Received | 2017-01-30 |
| Date Added to Maude | 2017-01-12 |
| 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 | EPTFE VASCULAR GRAFT |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2017-01-12 |
| Catalog Number | UNKNOWN GRAFT |
| 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 | 2017-01-12 |