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

Catalog Number	RBYPODJ30
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	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 using a lantern delivery microcatheter (lantern), pod packing coils (packing coil), a non-penumbra coil, a intermediate catheter and a guiding catheter.It should be noted that the patient's anatomy was moderately tortuous and moderately calcified.During the procedure, the physician advanced the lantern through the intermediate catheter and the guiding catheter, and successfully implanted the non-penumbra coil and one of the packing coils into the target vessel.While attempting to insert another packing coil, the physician experienced resistance, and the packing coil could not be advanced beyond the mid-shaft of the lantern.Therefore, the packing coil was retracted from the lantern.After flushing the lantern, the physician re-inserted the lantern and attempted to advance the same packing coil.However, stronger resistance was experienced, and the packing coil could not be advanced beyond the mid-shaft of the lantern.It was reported that the packing coil was unintentionally detached, believed to have detached while being pulled back.Therefore, the lantern containing the packing coil was removed from the patient, and the packing coil was flushed out of the lantern.The procedure was completed using a new 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 packing coil (packing coil) confirmed that the embolization coil was unintentionally detached.Evaluation revealed that the pet lock was intact, and the pull wire was in its initial position within the distal end of the pusher assembly.If the packing coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detaching.Based on the reported event, the root cause of resistance during the procedure could not be determined.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 PACKING 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: 22287060
• Report Number: 3005168196-2025-00208
• Device Sequence Number: 18366051
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170852
• 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): 07/17/2025

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: RBYPODJ30
• Device Lot Number: F00012358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown