MAUDE Adverse Event Report: PENUMBRA, INC. PACKING COIL LP; HCG, KRD

Catalog Number	RBYPCLP60
Medical Device Problem Codes	Failure to Fold (1255); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the iliac artery using packing coil lps and a non-penumbra microcatheter.During the procedure, the physician successfully implanted multiple lp coils into the target location.While advancing a packing coil lp into the target location, the physician met resistance.The physician retracted the packing coil lp and re-advanced it into the vessel; however, the coil would not take its intended shape and remained stiff and straight.The physician attempted to re-advance the coil twice, but the same issue occurred.The physician then decided to remove the packing coil lp.While retracting the packing coil lp, the coil unintentionally detached partially in the patient's anatomy and partially in the microcatheter.The physician attempted to flush the microcatheter with saline to push the detached packing coil lp into the target vessel; however, it would not move.The physician then advanced a guide wire into the microcatheter and attempted to push the packing coil lp into the vessel; however, it would not move.While exerting additional force to move the coil, the microcatheter backed out of the vessel.A snare device was then advanced to the packing coil lp.While removing the coil with the snare, the packing coil lp stretched and fractured.An angiogram was performed, and the fractured segment of packing coil lp was seen partially in the aortic aneurysm with the end within the internal iliac artery.The procedure was considered completed.There was no report of an adverse effect to the patient.

• Brand Name: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21097437
• Report Number: 3005168196-2025-00004
• Device Sequence Number: 8775869
• Product Code: HCG
• UDI-Device Identifier: 00815948021952
• UDI-Public: 00815948021952
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2025

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 Expiration Date: 05/16/2026
• Device Catalogue Number: RBYPCLP60
• Device Lot Number: F106286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2021
• 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 Age: 80 YR
• Patient Sex: Male