MAUDE Adverse Event Report: PENUMBRA, INC. POD COIL; 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	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod coils, pod packing coils (packing coil), a guiding catheter, a non-penumbra catheter, and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was mildly tortuous and mildly calcified.During the procedure, while inserting the first pod coil into the microcatheter, the physician experienced resistance while advancing the pod coil at the mid-shaft of the microcatheter and was unable to advance the coil further.After advancing and retracting the pod coil within the microcatheter several times, the physician observed under fluoroscopy that the pod coil had unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed from the patient, and the pod coil was flushed out of the microcatheter.The procedure was completed using pod coils, packing coils and the same microcatheter.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 unintentionally detached.Evaluation revealed that the distal tip of the pull wire was advanced distal to the distal detachment tip of the pusher assembly.If the pod coil is manipulated against resistance during use, the pull wire may advance distal to the pusher assembly distal detachment tip and cause the embolization coil to detach.The reported mildly tortuous and mildly calcified anatomy may have contributed to the resistance experienced during procedure.Further evaluation revealed kinks on the pusher assembly and offset coil winds on the embolization coil.This damage is incidental to the complaint.The kink may have occurred during packaging of the device for return to penumbra.The offset coil winds may have occurred during manipulation of the pod coil against resistance.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.

• Brand Name: POD COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21463154
• Report Number: 3005168196-2025-00061
• Device Sequence Number: 9182041
• Product Code: HCG
• UDI-Device Identifier: 00814548019611
• UDI-Public: 00814548019611
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: F00009255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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: Unknown