MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-11 for CARBOFLO VASCULAR GRAFT 40A74C manufactured by Bard Peripheral Vascular, Inc..
[35992569]
A further clinical review of the event details was completed and a change in the mdr reportability was identified. No medical records or no medical images have been made available to the manufacturer. As the serial number for the device was provided, a review of the device history records is currently being performed. The device has 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
[35992570]
It was reported that prior to placement in the patient, the vascular graft was noted to be leaking. The graft was not used in the patient.
Patient Sequence No: 1, Text Type: D, B5
[40964785]
Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event. Visual inspection: the graft appeared to be clean. The graft had two blue lines running longitudinally down the graft and had carbon lining. There were no signs of rips, holes or tears along the graft. There were no suture holes observed at the edges of the graft. Based on the condition of the returned sample, it appears that the graft was not likely to have been implanted into the patient, and that the reported leak occurred during preparation. A few small grey spots were identified due to the graft's carbon lining. The grey coloring of the graft could indicate a possible break of the graft's hydrophobic barrier. This could potentially lead to graft leakage. Dimensional evaluation: the graft measured approximately 42. 4 cm long. This measurement was within specification. 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 complaint investigation is inconclusive for graft leaks as the reported conditions of use could not be recreated. Based on the condition of the returned graft, it did not appear that the graft had been implanted, and that the leak occurred during preparation. Per the complaint comments, the graft was flushed. Per the ifu, "exposure to solutions (e. G. , alcohol, oil, aqueous solutions, etc. ) may result in loss of the graft's hydrophobic properties. Loss of the hydrophobic barrier may result in graft wall leakage. Preclotting of this graft is unnecessary. " therefore, the probable root cause is likely user related. Labeling review: the current instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device. 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
| Report Number | 2020394-2016-00071 |
| MDR Report Key | 5356844 |
| Date Received | 2016-01-11 |
| Date of Report | 2014-01-09 |
| Date of Event | 2013-12-09 |
| Date Mfgr Received | 2016-03-18 |
| Device Manufacturer Date | 2012-04-02 |
| Date Added to Maude | 2016-01-11 |
| 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 WEST 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 WEST 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 | CARBOFLO VASCULAR GRAFT |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2016-01-11 |
| Returned To Mfg | 2014-01-28 |
| Catalog Number | 40A74C |
| Device Expiration Date | 2017-03-31 |
| 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 WEST 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-11 |