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	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 ovarian vein using pod coils and a lantern delivery microcatheter (lantern).During the procedure, a pod coil unintentionally detached inside the lantern.Therefore, the lantern containing the detached pod coil was removed and the pod coil was removed on the back table.The lantern was then flushed and re-advanced into the target location.The procedure was completed using another pod coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 10/02/2024: section a.Box 3.Sex.Section b.Box 5.Describe event or problem.Section h.Box 6.Device code 2.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ovarian vein using pod coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing the pod coil through the lantern around a bend in the patient's anatomy, the physician experienced resistance and the pod coil unintentionally detached in the middle of the lantern.Therefore, the lantern containing the detached pod coil was removed and the pod coil was flushed out on the back table.The procedure was completed using another pod coil 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: 20209698
• Report Number: 3005168196-2024-00318
• Device Sequence Number: 7450616
• Product Code: HCG
• UDI-Device Identifier: 00814548019635
• UDI-Public: 00814548019635
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024
• 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: F00010472
• Was Device Available for Evaluation?: No
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2024
• 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: 40 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005