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

Catalog Number	RBYPOD5
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	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using a lantern delivery microcatheter (lantern) and a pod coil.During the procedure, while inserting the pod coil into the lantern, the pod coil felt slow to advance and the physician experienced resistance.The physician then attempted to retract the pod coil and found that the pod coil had unintentionally detached within the proximal length of the lantern.Therefore, the pod coil was removed.The procedure was completed using a new pod coil, a pod packing coil (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embolization coil was detached.Evaluation revealed that the pusher assembly was kinked and fractured, and the pull wire was retracted out of the distal end of the pusher assembly.If the pod coil is advanced against resistance, damage such as a kink and fracture may occur.Based on the reported event, the root cause of resistance could not be determined.The embolization coil likely detached due to the pusher assembly fracture.Further evaluation revealed kinks along the length of the pusher assembly and offset coil winds on the embolization coil.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.
Additional Manufacturer Narrative
Please note that the following sections is being updated based on additional information provided by the distributor on 08/27/2024: section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using a lantern delivery microcatheter (lantern) and a pod coil.During the procedure, while inserting the pod coil into the lantern, the pod coil felt slow to advance and the physician experienced resistance.The physician then attempted to retract the pod coil and found that the pod coil had unintentionally detached within the proximal length of the lantern.Therefore, the pod coil was removed.It was reported that the pod coil was flushed out of the lantern.The procedure was completed using a new pod coil, a pod packing coil (packing coil), and the same lantern.There was no report of an adverse effect to the patient.

• 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: 20081764
• Report Number: 3005168196-2024-00298
• Device Sequence Number: 18058417
• Product Code: HCG
• UDI-Device Identifier: 00814548019604
• UDI-Public: 00814548019604
• 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,Followup
• Report Date (Section B): 09/11/2024
• 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: RBYPOD5
• Device Lot Number: F105399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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: Female
• Date Report Sent to FDA: 01/01/2005