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

Catalog Number	RBYPODXL1255
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod xl confirmed that the embolization coil was fractured and unraveled.Based on the reported event, the embolization coil likely fractured while snaring for removal.If the pod xl is retracted against resistance, damage such as sr component fracture may occur causing embolization coil to unravel.Based on the reported event, the detached embolization coil became wrapped around the catheter during repositioning, which may have contributed to resistance during retraction.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the innominate artery using a pod xl, and a catheter.During the procedure, after the pod xl was placed in the target location, the pod xl migrated to the subclavian artery.The physician advanced the catheter to reposition the detached embolization coil back into the coil mass; however, the coil became wrapped around the catheter.The catheter was retracted, and the detached embolization coil was pulled back.A snare device was used to retrieve the coil, but the embolization coil fractured.The physician performed a surgical cutdown of the right radial artery to remove the fractured embolization coil.The procedure ended at this point.

• Brand Name: POD 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: 24059323
• Report Number: 3005168196-2026-00016
• Device Sequence Number: 13135165
• Product Code: KRD
• UDI-Device Identifier: 00810169721759
• UDI-Public: 00810169721759
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/13/2026

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: RBYPODXL1255
• Device Lot Number: F00017605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• 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