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

Catalog Number	RBYPODJ15
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery using pod packing coils (packing coil) and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was mildly tortuous and mildly calcified.During the procedure, the physician successfully implanted one packing coil into the target vessel using the microcatheter.Another packing coil was advanced into the target vessel; however, the packing coil would not anchor properly.While advancing and retracting the packing coil, the coil unintentionally detached.Therefore, the microcatheter containing the detached packing coil was removed from the patient.The procedure was completed using a non-penumbra microcatheter and two non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned embolization coil confirmed that the embolization coil was detached from its pusher assembly, and the pusher assembly was not returned for evaluation.Based on the return condition, the root cause of the reported complaint could not be determined.Further evaluation revealed offset coil winds on the embolization coil.This damage is likely incidental to the complaint and may have occurred due to manipulation against resistance during use.The reported mildly tortuous and mildly calcified patient¿s anatomy may have contributed to resistance during the procedure.Penumbra coils 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.

• 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: 20403654
• Report Number: 3005168196-2024-00342
• Device Sequence Number: 17707634
• Product Code: HCG
• UDI-Device Identifier: 00814548017648
• UDI-Public: 00814548017648
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2024
• 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: RBYPODJ15
• Device Lot Number: F00005796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2024
• 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: 09/12/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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: 81 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005