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

Catalog Number	RBYPOD8
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod coil confirmed that the embolization coil was detached from the pusher assembly.The pusher assembly was not returned for evaluation.Therefore, the root cause of the coil detachment or the reported advancement issue during the procedure could not be determined.Penumbra coils are 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 in the internal iliac artery (iia) using pod coils, pod packing coils (pod pc), and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully implanted two pod coils and three pod pcs into the target vessel using the lantern.After advancing a small part of another pod coil out of the lantern, the pod coil would not advance any further.The physician then decided to remove the pod coil and while removing, the pod coil unintentionally detached within the lantern.Therefore, the lantern containing the pod coil was removed.It was reported that the pod coil was then flushed out of the lantern.The procedure was completed using a new pod coil, three pod pcs, and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD 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: 18754561
• Report Number: 3005168196-2024-00057
• Device Sequence Number: 6517095
• Product Code: HCG
• UDI-Device Identifier: 00814548019635
• UDI-Public: 814548019635
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• 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): 02/21/2024
• 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: RBYPOD8
• Device Lot Number: F113521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• 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: 01/24/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005