MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. PTFE FELT PLEDGETS; SURGICAL

Catalog Number	007971
Medical Device Problem Codes	Leak/Splash (1354); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: 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.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2027).H11: section a through f ¿ the information provided by bd represents all 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 a surgical graft placement procedure, during haemostasis, at the second clamping, the new aortic suture was allegedly loosened with a massive leakage which required a third one hundred and seventy six minute clamping.It was further reported that the teflon patch allegedly went into the patient's bloodstream.Reportedly, the patient was needed to be reopened and was placed under cardiovascular examination along with rapid recovery and close neurological monitoring was done due to the missing piece of teflon.The current status of the patient is unknown.
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 unsealed and one sealed impra eptfe patches were received for evaluation.During visual on the unsealed evaluation, it was noted that the sample appeared to have residue throughout, and frayed fibers were noted on both sides of the patch.Holes were also observed on the center of both sides of the patch.No other anomalies were noted.Upon dimensional evaluation, the thickness of the pledget was measured and found to be within acceptable range.One electronic photo was provided for review.The photo shows a contaminated pledget placed in a containment cup.Therefore, the investigation is inconclusive for the reported failures as no objective evidence was provided to confirm the reported event.A definitive root cause for the alleged leak and migration issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 05/2027), g3, h6 (device) h11: h6 (method, result, conclusion) h11: section a through f ¿ the information provided by bd represents all 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 a surgical graft placement procedure, during hemostasis, at the second clamping, the new aortic suture was allegedly loosened with a massive leakage which required a third one hundred and seventy-six-minute clamping.It was further reported that the teflon patch allegedly went into the patient's bloodstream.Reportedly, the patient was needed to be reopened and was placed under cardiovascular examination along with rapid recovery and close neurological monitoring was done due to the missing piece of teflon.The current status of the patient is unknown.

• Brand Name: PTFE FELT PLEDGETS
• Common Device Name: SURGICAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18825283
• Report Number: 2020394-2024-00303
• Device Sequence Number: 15390801
• Product Code: DXZ
• UDI-Device Identifier: 00801741041358
• UDI-Public: (01)00801741041358
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNKNOWN
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 007971
• Device Lot Number: HUGT1667
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Unknown