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

Model Number	F8007TWSC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 02/2025).
Event or Problem Description
It was reported that during a vascular graft placement procedure, the device allegedly broke.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 product/lot number combination.Therefore, a device history record review is not required.Investigation summary: one impra carboflo graft in four segments were returned for evaluation.Gross visual evaluation was performed.The sample appeared to be bloody.Segment one measures approximately 38.5 cm.It was noted the beads were dislodged on one end.In addition there was a hole in the graft and the bead was broken approximately 34.4 cm from the distal end.Segment two measures approximately 28.0 cm.There was portion that was flattened approximately 22.0 cm from the distal end.Segment three measures approximately 11.8 cm from end to the flared end.Segment four measured approximately 1.6 cm in length and the beading was dislodged at one end.No sutures noted.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.The definitive root cause for the reported torn material issue could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11: section a through f ¿ the information provide by bd represents all 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 a vascular graft placement procedure, the device allegedly broke.There was no reported patient injury.

• Brand Name: IMPRA EPTFE 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: 10893658
• Report Number: 2020394-2020-20576
• Device Sequence Number: 14226815
• Product Code: DSY
• UDI-Device Identifier: 00801741021633
• UDI-Public: (01)00801741021633
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 06/02/2021

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: F8007TWSC
• Device Catalogue Number: F8007TWSC
• Device Lot Number: VTEP0634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 06/03/2021
• 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