MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CARBOFLO VASCULAR GRAFT; EPTFE VASCULAR GRAFT

Model Number	40A64C
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.A photo was provided.The lot number for the device was provided.The device history records and photo are currently under review.The return of the device is pending.The investigation is currently under way.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.
Event or Problem Description
It was reported that during an angiography approximately 50 days post procedure, the inner lumen surface of the vascular graft was allegedly not smooth and something tattered was found.It was further reported that the health care provider (hcp) punctured the graft and allegedly retrieved a film-like substance.Reportedly, a second procedure was performed to remove and replace the vascular graft with another.Upon completion of the second procedure, the hcp recanted the allegation of foreign material as it did not originate from the graft.The patient was reported as recovering through dialysis with hd catheter post second procedure.
Event or Problem Description
It was reported that during an angiography approximately 50 days post procedure, the inner lumen surface of the vascular graft was allegedly not smooth and something tattered was found.It was further reported that the health care provider (hcp) punctured the graft and allegedly retrieved a film-like substance.Reportedly, a second procedure was performed to remove and replace the vascular graft with another.Upon completion of the second procedure, the hcp recanted the allegation of foreign material as it did not originate from the graft.The patient was reported as recovering through dialysis with hd catheter post second procedure.
Additional Manufacturer Narrative
A manufacturing review was not performed as the lot number was not provided.The device was not returned for evaluation.Medical records were not provided for review.One photo was provided and reviewed.The photo shows a film like substance laid out on a paper towel.However, it is unknown what the substance is.Therefore, the investigation is inconclusive for foreign material.Per the event details, the foreign material was not from the vascular graft.The alleged film like substance is most likely from a clot or tissue growth.However, the definitive root cause is unknown.A review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

• Brand Name: CARBOFLO VASCULAR GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7787478
• Report Number: 2020394-2018-01476
• Device Sequence Number: 1985605
• Product Code: DSY
• UDI-Device Identifier: 00801741020995
• UDI-Public: (01)00801741020995
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40A64C
• Device Catalogue Number: 40A64C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention