MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-17 for DISTAFLO MINI BYPASS GRAFT DFX9006SC manufactured by Bard Peripheral Vascular, Inc..
[70330883]
No medical records and no medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The return of the device is pending. 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
[70330884]
It was reported that during a bypass graft implantation from the right femoral artery to the right anterior tibial artery, the bypass graft allegedly tore while positioning it distally. Reportedly, the graft was removed and the health care provider switched to another site and successfully implanted another bypass graft. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[74733161]
The device history records have been reviewed with special attention to the subassemblies, manufacturing process, and quality control inspection. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. 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 was inconclusive for the alleged tear in the graft. Based upon the available information, the definitive root cause was unknown. Labeling review: the current instruction for use (ifu) states: eptfe grafts do not stretch (are non-elastic) in the longitudinal direction. The correct graft length for each procedure must be determined by considering the patient's body weight, posture, and the range of motions across the anatomical area of graft implantation. Failure to cut the graft to an appropriate length may result in anastomotic or graft disruption, leading to excessive bleeding, and loss of limb or limb function, and/or death. Aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage. When suturing, avoid excessive tension on the suture line, inappropriate suture spacing and bites, and gaps between the graft and host vessel. Failure to follow correct suturing techniques may result in suture hole elongation, suture pull-out, anastomotic bleeding and/or disruption. 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
[74733162]
It was reported that during a bypass graft implantation from the right femoral artery to the right anterior tibial artery, the bypass graft allegedly tore while positioning it distally. Reportedly, the graft was removed and the health care provider switched to another site and successfully implanted another bypass graft. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2017-00211 |
| MDR Report Key | 6415669 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-17 |
| Date of Report | 2017-04-24 |
| Date of Event | 2017-02-15 |
| Date Mfgr Received | 2017-04-19 |
| Device Manufacturer Date | 2016-09-24 |
| Date Added to Maude | 2017-03-17 |
| 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 | DISTAFLO MINI BYPASS GRAFT |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2017-03-17 |
| Catalog Number | DFX9006SC |
| Lot Number | VTAW0355 |
| 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 | 2017-03-17 |