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

Model Number F5006TWS

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date (06/2023).

Event Description

It was reported that the doctor was pulling the spiral off to cut the graft to size, the graft allegedly shredded for about 2 inches of length.It was also reported that it stopped shredding and the graft was still usable (as it had already been tunneled into place).

Manufacturer Narrative

H10: manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: one impra vascular graft was returned for evaluation which measured 3.6cm and had cut on both ends.Four tears were noted to the graft along with bead marks.No suture holes or sutures noted and no functional testing was performed due to the nature of the product received.Therefore based on the evidences the alleged failure torn graft is confirmed.The root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: d4 expiry date (06/2023), g4.H11: d10, h6(method, results).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

It was reported that the doctor was pulling the spiral off to cut the graft to size, the graft allegedly shredded for about 2 inches of length.It was also reported that it stopped shredding and the graft was still usable (as it had already been tunneled into place).

• Brand Name: IMPRA VASCULAR GRAFT
• Type of Device: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10156668
• MDR Text Key: 195216026
• Report Number: 2020394-2020-03949
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741023224
• UDI-Public: (01)00801741023224
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F5006TWS
• Device Catalogue Number: F5006TWS
• Device Lot Number: VTCT0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1