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

Catalog Number	RBYPCXL45
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	10/08/2025
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 in an abdominal aortic aneurysm (aaa) using a packing coil xl and a non-penumbra catheter.During the procedure, the physician experienced resistance while advancing the packing coil xl to the target location.The physician decided to remove the packing coil xl.While removing the coil, the pusher assembly kinked and fractured, causing the packing coil xl to detach inside the catheter.A snare device was used to remove the detached packing coil xl from the catheter.It was noted that the packing coil xl was unraveled when removed from the patient.The procedure was completed with a new packing coil xl and the same catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned packing coil xl confirmed that the embolization coil was detached from the pusher assembly.It was reported that the pusher assembly kinked and fractured during the procedure.If the packing coil xl is advanced against resistance, damage such as a kink may occur.Subsequent retraction of the kinked pusher assembly against resistance may cause a fracture and embolization coil detachment.The pusher assembly was not returned for evaluation; therefore, the root cause could not be determined.Evaluation also revealed that the pe fibers were fractured, and the coil winds were unraveled.This damage likely occurred during snaring of the detached embolization coil during the procedure.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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 23423142
• Report Number: 3005168196-2025-00350
• Device Sequence Number: 8179436
• Product Code: KRD
• UDI-Device Identifier: 00810169721575
• UDI-Public: 00810169721575
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: RBYPCXL45
• Device Lot Number: F00017510
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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: 79 YR
• Patient Sex: Male