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

Model Number	F4007
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, photo was provided for review.The investigation of the reported event is currently underway.Expiry date: 05/2025.
Event or Problem Description
It was reported that prior to surgical graft placement procedure, the ring of graft was allegedly found to be separated from the graft.There was no patient contact.
Event or Problem Description
It was reported that prior to surgical graft placement procedure, the ring of graft was allegedly found to be separated from the graft.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one graft in two segments were returned for evaluation.Gross visual evaluation was performed.Although sample was returned for evaluation, one photo was provided for review.The investigation is confirmed for the reported material split issue, as the graft was received two segments and the beading was noted to be slightly removed from graft where possible cut was made.A definitive root cause could not be determined based upon the provided 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.H10: d4(expiry date: 05/2025), g3 h11: h6(result and conclusion) 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.H3 other text : see h10.

• Brand Name: IMPRA EPTFE VASCULAR GRAFT
• Common Device Name: IMPRA VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11723133
• Report Number: 2020394-2021-00914
• Device Sequence Number: 14340265
• Product Code: DSY
• UDI-Device Identifier: 00801741022708
• UDI-Public: (01)00801741022708
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: F4007
• Device Catalogue Number: F4007
• Device Lot Number: VTES0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/18/2021
• 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