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

Catalog Number	RBYPCXL55
Medical Device Problem Codes	Fracture (1260); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
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 splenic artery using a packing coil xl, pod xls, and a non-penumbra catheter.During the procedure, the physician placed two pod xl coils and one packing coil xl in the target location.While advancing another packing coil xl through the catheter, the physician experienced resistance and noticed the packing coil xl had fractured and unraveled.It was reported the fractured portion of the packing coil xl that was still attached to the pusher assembly was removed, and the other partially fractured piece of the packing coil xl was inside the catheter.The physician attached a syringe to the catheter and pulled negative pressure through the catheter, and the catheter was removed containing the packing coil xl.The entire packing coil xl was removed successfully, and no part of the packing coil xl was left in the patient.The procedure had ended at this point.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 fractured and unraveled.Evaluation revealed that the pe fibers were fractured.If the packing coil xl is manipulated against resistance, damage such pe fibers fracture may occur.The pe fibers fracture likely caused the embolization coil to fracture and unravel.Based on the reported event, the root cause of resistance during the procedure could not be determined.Some of the embolization coil unraveling may have occurred during retraction of the fractured coil from 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: 23660153
• Report Number: 3005168196-2025-00380
• Device Sequence Number: 10124168
• Product Code: KRD
• UDI-Device Identifier: 00810169721582
• UDI-Public: 00810169721582
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/22/2026

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: F00017836
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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: 64 YR
• Patient Sex: Male