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 2017-09-20 for IMPRA EPTFE VASCULAR GRAFTS 10S035 manufactured by Bard Peripheral Vascular, Inc..
[88146577]
No hospital/medical records or medical images have been made available 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 has not been returned to the manufacturer for evaluation. The investigation of the reported event 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
[88146578]
It was reported that during implant of a vascular graft in a pediatric pulmonary shunt procedure, visual inspection allegedly identified excessive graft wall leakage. No other pertinent information was provided leading up to or surrounding the event. There was no report of a vascular graft replacement. The patient status was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2017-01184 |
| MDR Report Key | 6881537 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-20 |
| Date of Report | 2017-10-23 |
| Date Mfgr Received | 2017-10-20 |
| Date Added to Maude | 2017-09-20 |
| 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 | IMPRA EPTFE VASCULAR GRAFTS |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2017-09-20 |
| Catalog Number | 10S035 |
| 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 | 2017-09-20 |