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

Model Number	100P15006
Medical Device Problem Codes	Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.The information provided by bard 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 bard.
Event or Problem Description
It was reported that foreign material was allegedly discovered on the cardiovascular patch upon opening the package.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one cardiovascular patch was returned for evaluation.The device was returned in the inner packaging tray, however the device was opened.Creases and indentations were identified along the length of the returned device.Based on the returned device, the investigation can be confirmed for the identified creases and indentations (nonstandard device or device component).The investigation is inconclusive for the alleged foreign material; the device was returned open and no foreign material was present.The user could have identified the marks in the device as foreign material.Based upon the available information, the definitive root cause is unknown.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that foreign material was allegedly discovered on the cardiovascular patch upon opening the package.There was no patient contact.

• Brand Name: IMPRA EPTFE CARDIOVASCULAR PATCH
• Common Device Name: CARDIOVASCULAR PATCH
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7268634
• Report Number: 2020394-2018-00095
• Device Sequence Number: 1994493
• Product Code: DXZ
• UDI-Device Identifier: 00801741041457
• UDI-Public: (01)00801741041457
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K905073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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: Other
• Device Expiration Date: 03/02/2021
• Device Model Number: 100P15006
• Device Catalogue Number: 100P15006
• Device Lot Number: VTAQ0109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1