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

Catalog Number	RBYPODJ15
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod packing coil (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, while the physician was advancing the packing coil through the mid-shaft of the microcatheter, the packing coil became stuck, and the physician kinked the pusher assembly.When pulling the pusher assembly back, the packing coil unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached packing coil was removed.It was reported that the packing coil was flushed out of the microcatheter on the back table.The procedure was completed using three non-penumbra coils, along with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned packing coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact on the proximal end, the pusher assembly was fractured, and the pull wire was retracted from its original position on the distal end of the pusher assembly.If the pusher assembly is advanced against resistance, damage such as a kink may occur.Further manipulation of the kinked device may worsen to a fracture.The patient¿s tortuous anatomy may have contributed to resistance during the procedure.The fracture on the pusher assembly likely contributed to the embolization coil detaching from its pusher assembly.Further evaluation revealed an additional kink on the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra devices 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.

• 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: 20606038
• Report Number: 3005168196-2024-00373
• Device Sequence Number: 20718547
• 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): 11/04/2024
• 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: F00010975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• 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: 10/10/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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: Male
• Date Report Sent to FDA: 01/01/2005