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

Catalog Number	RBYPODJ30
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod pc confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pusher assembly was fractured, and the pull wire was retracted completely out of the distal fractured segment of the pusher assembly.If the pod pc is advanced against resistance, damage such as a kink may occur.Subsequent manipulation and retraction of the kinked device likely contributed to the pusher assembly fracture.Separation of two fractured segments likely resulted in the pull wire being retracted from its original position, and the embolization coil detachment from its pusher assembly.Further evaluation revealed kink in the pusher assembly.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra products 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 abdominal aorta using pod packing coils (pod pcs) and non-penumbra microcatheters.During the procedure, the physician successfully implanted nine non-penumbra coils using one microcatheter and two pod pcs using the other microcatheter.While advancing the next pod pc in the middle of the microcatheter, resistance was encountered.Upon retraction, resistance was also encountered and, subsequently, the pod pc unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached pod pc was removed from the patient, and the coil was flushed out on the back table.The procedure was completed using the same microcatheter to successfully implant four pod pcs.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2022-00579.1.Section h.Box 10./11.Narrative/corrected evaluation of the returned pod pc confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pusher assembly was fractured, and the pull wire was retracted.If the pod pc is advanced against resistance, damage such as a kink may occur.Subsequent manipulation and retraction of the kinked device likely contributed to the pusher assembly fracture.Separation of two fractured segments likely resulted in the pull wire being retracted from its original position, and the embolization coil detachment from its pusher assembly.Further evaluation revealed kink in the pusher assembly.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra products 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.H3 other text : placeholder.

• 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: 16019172
• Report Number: 3005168196-2022-00579
• Device Sequence Number: 5705577
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 814548017655
• 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,Followup
• Report Date (Section B): 12/21/2022
• 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: F00000918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• 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: 01/14/2005
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005