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

Catalog Number	RBYPODJ30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pc confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, and the pull wire was in its original position on the distal end of the pusher assembly.If the pc is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and the embolization coil may detach from its pusher assembly.The ovalization on the distal end of the lantern likely contributed to the resistance.The pc embolization coil was detached within the ovalized location of the lantern.Penumbra devices are 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 hypogastric artery using packing coils (pc), a pod coil, a lantern delivery microcatheter (lantern), a non-penumbra catheter (.038), and a guidewire.During the procedure, the lantern was advanced through a non-penumbra catheter into the target location.It was reported that one pod coil was successfully implanted.The physician then attempted to advance a pc through the lantern; however, the lantern kicked back.Upon re-advancing, the lantern would not advance through the non-penumbra catheter.It was noted that the lantern may have been kinked.Therefore, the physician retracted the pc and noticed that the coil had unintentionally detached within the lantern.The lantern was then removed containing the detached pc.After removal, the lantern was noticed to be kinked at the distal end.The lantern was attempted to be flushed; however, the detached pc was stuck at the kinked location and would not flush out.The procedure was completed using a new pc, a non-penumbra microcatheter, and the same non-penumbra catheter.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 18964359
• Report Number: 3005168196-2024-00097
• Device Sequence Number: 8161858
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 814548017655
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2024
• Report Date (Section F): 01/01/2005

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: RBYPODJ30
• Device Lot Number: F00008252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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: 75 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005