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 DISTAFLO MINI BYPASS GRAFT DFX6006SC manufactured by Bard Peripheral Vascular, Inc..
[64735173]
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 device has been returned for evaluation. 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
[64735174]
It was reported that after completion of the distal anastomosis, without trauma, two alleged slices were identified in the prosthesis, near the anastomosis. Reportedly, another vascular graft was used and the procedure was completed. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[69146179]
Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint that has been reported for this corporate lot number to date. Visual inspection: the two segments had two blue lines running down the length of the graft and carbon inner lining, thus identifying it as a bard product. The first segment measured 62. 6cm from the cut and/or torn end of the graft to the distal end of the graft. The beading was intact along the length of the segment. No tear, perforation, sutures, or suture holes were present along the length of the segment. The second segment measures approximately 2. 0cm in length. The segment was noted to be torn and twisted. There was a suture present in the segment. Segment of the graft measured approximately 64. 6cm in total length. This measurement was within specification. Therefore, the entirety of the graft was returned for evaluation. Functional/performance evaluation: the sample was returned; however, functional/performance evaluation was not required for this device. 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 returned. The investigation was confirmed for torn material, as the second segment returned exhibited a tear around the suture. It was unknown if procedural issues contributed to the reported event. Based on the available information, the definitive root cause was unknown. Labeling review: the current instruction for use (ifu) states: 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. The distal anastomosis should be made after tunneling or suture disruption can occur. Do not pass the cuff portion (distal end) of the distaflo bypass graft through a tunneler sheath or the tissue tunnel, as this could lead to separation of the spiral beading and/or graft breakage. Distaflo bypass 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. 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. Size the graft appropriately to minimize excessive tension at the suture line. Use a tapered, non-cutting needle with a nonabsorbable monofilament suture approximately the same size as the needle. Take 2 mm suture bites in the graft following the curve of the needle and gently pull the suture at a 90? Angle. Proper sizing of the graft length prior to implant will minimize suture hole elongation caused by excessive tension. To avoid extreme stress on the anastomosis and the graft, include the patient? S weight and range of limb motion when determining graft length, tunnel length and location. To determine the correct graft length, drape the patient to allow full movement of the arm, shoulder girdle or legs. Cutting the graft slightly longer than necessary has been reported by some surgeons to further reduce the risk of stressing the graft or the anastomosis. (b)(4). 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
[69146180]
It was reported that after completion of the distal anastomosis in the lower extremities, without trauma, two alleged slices were identified in the prosthesis, near the anastomosis. Reportedly, another vascular graft was used and the procedure was completed. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-01258 |
| MDR Report Key | 6247698 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-12 |
| Date of Report | 2016-12-20 |
| Date of Event | 2016-12-19 |
| Date Mfgr Received | 2017-02-23 |
| Device Manufacturer Date | 2016-05-31 |
| 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 | DISTAFLO MINI BYPASS GRAFT |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2017-01-12 |
| Returned To Mfg | 2017-01-06 |
| Catalog Number | DFX6006SC |
| Lot Number | VTAS0740 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |