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

Catalog Number	RBYPCXL30
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left main pulmonary trunk using pod coils, a pod packing coil (packing coil), packing coil xls, a non-penumbra catheter, and a non-penumbra microcatheter.During the procedure, the physician placed eight pod coils, one packing coil, and three packing coil xls in the target location.After placing a final packing coil in the target location, the physician performed a fluoroscopy and noticed the coils placed in the target site had shifted.It was reported the tail end of the 30cm packing coil xl had come out of the target location and was in an adjacent pulmonary trunk that was medial and lateral to the target site.The physician used a snare device to successfully remove the 30cm packing coil xl.The procedure had ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 23587338
• Report Number: 3005168196-2025-00369
• Device Sequence Number: 15828953
• Product Code: KRD
• UDI-Device Identifier: 00810169721568
• UDI-Public: 00810169721568
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/18/2025

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: RBYPCXL30
• Device Lot Number: F00018381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2025
• 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: 65 YR
• Patient Sex: Female