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

Model Number 40A74C

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

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 under way.

Event Description

It was reported that during implantation of the vascular graft, the graft allegedly leaked.There was no reported patient injury.

Event Description

It was reported that during implantation of the vascular graft, the graft allegedly leaked.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and 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 reported to date for this lot number and failure mode.Investigation summary: one partial carboflo graft was returned for evaluation.The returned graft leaked during wep testing in a discolored location.It was then leak tested again in another location and passed.However, it can be confirmed for leak.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Label review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: CARBOFLO VASCULAR GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8140316
• MDR Text Key: 129583853
• Report Number: 2020394-2018-02173
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021008
• UDI-Public: (01)00801741021008
• Combination Product (y/n): N
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40A74C
• Device Catalogue Number: 40A74C
• Device Lot Number: VTBU0514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1