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

Model Number	100P15006
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Open or Remove Packaging Material (2922); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of a procedure, the patches allegedly had a deposit appearance.There was no patient contact.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiration date: 03/2027.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 preparation of a procedure, the patches allegedly had a deposit appearance.It was further reported that device had sticky issue.Reportedly, the material thickness was allegedly out of specification.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one impra eptfe patch was returned for evaluation along with one eptfe patch that has been further processed (e.G., cut, stretched, and heated).Upon opening the eptfe patch from its packaging, one side of the eptfe patch was noted to be stuck to the inner tyvek packaging label.One electronic video was also provided and reviewed.The video is showing, the opening of the impra eptfe patch by the physician.While opening the package the patch was noted to be sticking to the packaging label.Furthermore, the additional investigation showed that when using the current validated oq settings for sealing cvp 100p15006, the patches did adhere to the tyvek.This phenomenon is limited to cvp 100p15006 because it is the only patch that is folded in half during packaging due to its size.All patches use the same packaging trays and sealer settings.Based on post seal testing, returned sample, and provided video the investigation is confirmed for the alleged packaging issue.However, this adherence was shown to not have a negative impact on the product.In addition, four readings were taken to measure the thickness of the impra eptfe patch.The measured thickness of the patch was within the specification.Therefore, the investigation is unconfirmed for the reported non-standard device issue.Of the two returned patches, only the further processed (i.E., cut, stretched, and heated) patch shows discoloration; however, it was reported that the discoloration was observed after further thermal in processing was performed by the customer.The impra eptfe patch received within the sealed packaging does not show discoloration.Two photos were provided and reviewed.The photos show what appears to be an eptfe patch with brown discolorations.However, no statement of lot number nor any other indication of the specific product is provided.Based on the available information, the investigation is inconclusive for the reported discoloration issue.A definitive root cause for the alleged device contamination, packaging issue, and non-standard device 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: b5, d4 (expiration date: 03/2027), g3, h6 (device).H11: h6 (method, result, 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.

• 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
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14849538
• Report Number: 2020394-2022-00520
• Device Sequence Number: 19428037
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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: 100P15006
• Device Catalogue Number: 100P15006
• Device Lot Number: VTGQ0631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown