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

Catalog Number	RBYPODJ45
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod pc confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pusher assembly was kinked and had a fracture at the kinked location.The detached embolization coil likely occurred due to the pusher assembly fracture.If the pod pc is advanced against resistance, damage such as a kink and subsequent fracture may occur.The root cause of resistance could not be determined.Further evaluation revealed additional kinks on the pusher assembly.This damage likely occurred during attempts to advance the coil against resistance.Penumbra devices 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an endoleak in the thoracic aortic artery using pod packing coils (packing coils), ruby coils, and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully implanted five ruby coils and ten packing coils into the target vessel using the lantern.While advancing another packing coil through the proximal length of the lantern, the physician experienced resistance and decided to remove the packing coil.While making another attempt to advance the packing coil, resistance was still encountered.The physician then kinked the pusher assembly of the packing coil and the packing coil unintentionally detached.Therefore, the lantern containing the detached packing coil was removed.It was reported that the packing coil was flushed out of the lantern.The procedure was completed using a new packing coil and the same lantern.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: 19322856
• Report Number: 3005168196-2024-00185
• Device Sequence Number: 12342246
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 814548017662
• 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): 05/15/2024
• 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: RBYPODJ45
• Device Lot Number: F00006944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• 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: 04/24/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Date Report Sent to FDA: 01/01/2005