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

Catalog Number	RBYPODJ30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using pod packing coils (packing coil), non-penumbra coils, and a non-penumbra microcatheter.The physician successfully placed non-penumbra coils and packing coils into the target location.While advancing the next packing coil through the microcatheter, the physician experienced resistance, and decided to retract the packing coil.While retracting the packing coil, the embolization coil unintentionally detached.The microcatheter containing the detached embolization coil was removed from the patient.The procedure ended at this point.There was no report of an adverse affect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod packing coils (packing coil) confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, the pull wire was in its initial position inside the pusher assembly distal tip, and the embolization coil was detached and had offset coil winds.If the packing coil is advanced against resistance, damage such as offset coil winds may occur.Subsequently, if the packing coil is retracted against resistance, the pusher assembly may elongate and allow the embolization coil to detach.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.The offset coil winds may have contributed to resistance during retraction.Further evaluation revealed bends along the length of the pusher assembly.This damage was incidental to the complaint and may have occurred during packaging for return.Penumbra devices 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 25606422
• Report Number: 3005168196-2026-00210
• Device Sequence Number: 9802422
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: F00018303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• 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: 51 YR
• Patient Sex: Female