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

Catalog Number	RBYPODJ30
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned packing coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was wrinkled but intact on the proximal end of the pusher assembly, the pusher assembly was fractured in multiple locations along its length.If the packing coil is advanced against resistance, damage such as a kink may occur.Further manipulation of a kinked device may worsen to a fracture.Based on the reported event, the root cause of resistance could not be determined.The pusher assembly fracture likely contributed to the embolization coil detaching from its pusher assembly.Further evaluation revealed additional kinks along the length of the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text: placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a pod coil, pod packing coils (packing coil), a non-penumbra microcatheter (carry leon hf), and a non-penumbra sheath.During the procedure, the physician successfully implanted one pod coil and one packing coil into the target vessel using the microcatheter.While advancing another packing coil out of its sheath, the physician experienced resistance, but continued to advance the packing coil into the microcatheter.While advancing the packing coil through the mid-shaft of the microcatheter, the pull wire of the packing coil fractured, and the packing coil unintentionally detached.The physician then pulled the pusher assembly of the packing coil back; however, it fractured.While attempting to pull the pusher assembly out of the microcatheter, the fractured part of the pusher assembly separated and only the pull wire was removed.Therefore, the microcatheter containing the packing coil and fractured pusher assembly were removed.It was reported that the packing coil and fractured pusher assembly were flushed out of the microcatheter.The procedure was completed using four packing coils.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 19588575
• Report Number: 3005168196-2024-00228
• Device Sequence Number: 16979412
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2024
• Report Date (Section F): 01/01/2005

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 Catalogue Number: RBYPODJ30
• Device Lot Number: F00010160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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
• Date Report Sent to FDA: 01/01/2005