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

Catalog Number	RBYPOD14
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	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left subclavian artery, using a lantern delivery microcatheter (lantern) and a pod coil.It should be noted that the patient¿s anatomy was mildly tortuous and calcified.While advancing the pod coil through the proximal length of the lantern, the pod coil got stuck.Therefore, the pod coil was removed.The physician then flushed the lantern and attempted to advance the pod coil again; however, it got stuck and the coil unintentionally detached within the lantern.Therefore, the lantern containing the detached pod coil was removed.It was reported that the pod coil was flushed out of the lantern.The procedure was completed using new pod coils, pod packing coils (packing coil) and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod coil confirmed that the embolization coil was detached.Further evaluation revealed that the pusher assembly was fractured, the introducer sheath had been cut, and the distal fractured segment was not returned for evaluation.It was reported that the pod coil had gotten stuck inside the microcatheter.If the pod coil is manipulated against resistance, the pusher assembly may either elongate beyond the reach of the pull wire and allow the embolization coil to detach, or the pusher assembly may become kinked and may subsequently fracture, resulting in a detached embolization coil.Based on the return condition and the reported complaint, the root cause of the reported advancement issue could not be determined.Further evaluation also revealed offset coil winds on the embolization coil.This damage may have occurred due to the coil becoming stuck and flushed out during the procedure.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.H3 other text : placeholder.

• Brand Name: POD
• 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: 20450833
• Report Number: 3005168196-2024-00346
• Device Sequence Number: 8616545
• Product Code: HCG
• UDI-Device Identifier: 00814548019673
• UDI-Public: 00814548019673
• 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): 10/14/2024
• 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: RBYPOD14
• Device Lot Number: F108249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2024
• 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: 09/18/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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 Sex: Male
• Date Report Sent to FDA: 01/01/2005