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

Catalog Number	RBYPCXL55
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	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a collateral vessel using a packing coil xl, pod packing coils (packing coils), and a non-penumbra catheter (4f).During the procedure, the physician advanced a packing coil xl into the vessel, the physician experienced resistance.While retracting the packing coil xl, the embolization coil unintentionally detached within the catheter.The catheter containing the embolization coil was removed.The physician opened a lantern delivery microcatheter (lantern) and advanced a packing coil into the target vessel.While repositioning the packing coil, the embolization coil unintentionally detached within the vessel.A snare device was used to remove the detached embolization coil from the patient.The procedure was completed with 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 packing coil xl revealed that the pe fibers were fractured, and the embolization coil was unraveled.If the pod xl is retracted against resistance, the pe fiber may fracture causing the embolization coil to unravel.Evaluation also revealed the pet lock was intact, and the embolization coil was still intact with the pusher at the detachment mechanism.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation revealed bends along the pusher assembly and a kink at the proximal end.This damage was incidental to the reported complaint and may have occurred while snaring or packaging for return.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: PACKING COIL XL
• Common Device Name: 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: 24574542
• Report Number: 3005168196-2026-00068
• Device Sequence Number: 10355845
• Product Code: KRD
• UDI-Device Identifier: 00810169721582
• UDI-Public: 00810169721582
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K250079
• 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): 03/11/2026

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: RBYPCXL55
• Device Lot Number: F00017956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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: 29 YR
• Patient Sex: Unknown