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

Model Number 50S08TWC

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported leak issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiration date: 09/2025).

Event Description

It was reported that during a surgical graft placement procedure, the surgical graft allegedly leaked blood at the suture holes.It was further reported that the graft was removed.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: CARBOFLO
• Type of Device: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14768693
• MDR Text Key: 294582894
• Report Number: 2020394-2022-00495
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021220
• UDI-Public: (01)00801741021220
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2022

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: 50S08TWC
• Device Catalogue Number: 50S08TWC
• Device Lot Number: VTEW0075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1