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

Catalog Number	RBYPCXL45
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the main renal artery using packing coil xls, a non-penumbra non-braided catheter.During the procedure, the physician successfully placed two packing coil xl in the target location.While advancing a third packing coil xl through the microcatheter, the third packing coil xl unintentionally detached.The physician used a syringe to push the detached packing coil xl out of the microcatheter.It was noted that some of the detached packing coil xl was in the target location.The physician then pushed the detached packing coil xl into a branch of the main renal artery with a stent.The procedure was completed after stenting the main renal artery.

• 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
• MDR Report Key: 22929422
• Report Number: 3005168196-2025-00284
• Device Sequence Number: 18416166
• Product Code: KRD
• UDI-Device Identifier: 00810169721575
• UDI-Public: 00810169721575
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K250079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2026
• Device Catalogue Number: RBYPCXL45
• Device Lot Number: C00018421
• 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: 08/06/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male