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

Model Number 80S08

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 80s08, vascular graft, allegedly leaked post placement.The patient was a (b)(6) year old male weighing 86 kgs.There were no consequences to the patient.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The sample was not returned for evaluation, therefore, the investigation is inconclusive for the alleged leak and material split, cut, or torn.The product catalog number was revised and the malfunction was reassessed and the trending code 1354 - leak was added.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd 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 bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 80s08twc vascular graft allegedly experienced split, cut, or torn material.The patient was a 63 year old male weighing 86 kgs.There were no consequences to the patient.

• 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: 9194110
• MDR Text Key: 162452784
• Report Number: 2020394-2019-03961
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741022289
• UDI-Public: (01)00801741022289
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 80S08
• Device Catalogue Number: 80S08TWC
• Device Lot Number: VTAX0078
• Date Manufacturer Received: 03/30/2020
• Patient Sequence Number: 1