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

Catalog Number	RBYPOD6
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	06/24/2022
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 and was stuck inside the returned lantern.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, and the pull wire was in its initial position within the pusher assembly ddt.If the pod coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire, and the embolization coil may detach.Further evaluation revealed pusher assembly bends and kinks.This damage was incidental to the reported complaint and may have occurred during packaging for return to penumbra.Penumbra coils and catheters 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 in the internal iliac artery using a pod coil, a lantern delivery microcatheter (lantern), and a guidewire.During the procedure, while advancing the pod coil out of the lantern, the physician experienced resistance, and subsequently, the pod coil became stuck at approximately one centimeter outside of the lantern.The physician then decided to retract the pod coil.While retracting the pod coil, it unintentionally detached inside of the lantern.Next, the physician attempted to push the pod coil into the target vessel using a.025 guidewire.However; the attempt was unsuccessful.Therefore, the lantern containing the pod coil was removed.The procedure was completed using two additional pod coils, four pod packing coils (pod pc), and a non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were inadvertently missed on the initial mfr report and are being included on this follow-up #01 mfr report:3005168196-2022-00349.1.Section h.Box 8.Usage of device.2.Section h.Box 10./11.Additional narrative and/or corrected data 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: 15094907
• Report Number: 3005168196-2022-00349
• Device Sequence Number: 20095662
• Product Code: HCG
• UDI-Device Identifier: 00814548019611
• UDI-Public: 814548019611
• 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): 07/25/2022
• 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: RBYPOD6
• Device Lot Number: F108587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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 Age: 64 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005