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

Model Number	F8006TWSC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2023).
Event or Problem Description
It was reported that during the procedure through right femoral-popliteal bypass, the framework of the device allegedly detached when the surgeon took it in the hand.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this lot number and the lot met all release criteria.A device history record review is not required.Investigation summary: one carboflo graft in four segments were returned for evaluation.Gross visual evaluation was performed.The sample appeared to be bloody.Segment one measures approximately 38.1 cm and beading is intact.Segment two measures approximately 33.3 cm with two tears near loose beading.Segment three measures approximately 5.1 cm and slight tears noted on the graft.Segment four measured approximately 2.3 cm with one tear and no beadings at all.Therefore the investigation is confirmed for the reported torn material, as the sample was received in four segments and the bead was found to be broken.A definitive root cause for the alleged torn material 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.H10: d4 (expiry date: 10/2023), g3, h6 (method) 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 or Problem Description
It was reported that during the procedure through right femoral-popliteal bypass, the framework of the device allegedly detached when the surgeon took it in the hand.There was no reported patient injury.

• Brand Name: CARBOFLO
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• MDR Report Key: 12093815
• Report Number: 2020394-2021-01264
• Device Sequence Number: 3959515
• Product Code: DSY
• UDI-Device Identifier: 00801741021626
• UDI-Public: (01)00801741021626
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: F8006TWSC
• Device Catalogue Number: F8006TWSC
• Device Lot Number: VTCX0146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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: Other