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

Model Number 100P15006

Device Problems Nonstandard Device (1420); Difficult to Open or Remove Packaging Material (2922); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported that during preparation of a procedure, the patches allegedly had a deposit appearance.There was no patient contact.

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.

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: the physical device was not returned for evaluation.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.As the device was not returned and the alleged issues could not be confirmed based on the photos provided, the investigation for the alleged issues is inconclusive.However, additional analysis was performed on a set of packaged patches and found that three patches were all within material thickness specification.Although the investigation still remains inconclusive regarding the alleged non standard device issue, as the device was not returned for evaluation.One electronic video was 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.Based on the video review the packaging issue can be confirmed.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 and the 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.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, method).H11: h6(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.

Event 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.

• Brand Name: IMPRA EPTFE CARDIOVASCULAR PATCH
• Type of Device: 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: 14840070
• MDR Text Key: 295796215
• Report Number: 2020394-2022-00514
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00801741041457
• UDI-Public: (01)00801741041457
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K905073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100P15006
• Device Catalogue Number: 100P15006
• Device Lot Number: VTGQ0631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1