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

Catalog Number	RBYPODJ45
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	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod packing coil confirmed that the embolization coil was detached from the pusher assembly.It was reported that the embolization coil unintentionally detached, during manipulation within the parent catheter.Evaluation revealed that the sr component was fractured, and the proximal constraint sphere was not present on the returned embolization coil.This type of sr component fracture may occur if the pod packing coil is retracted against resistance during use.Based on the reported event, the root cause of the resistance could not be determined.Further evaluation of the device revealed offset coil winds on the embolization coil.Some of the offset coil winds may have occurred during advancement against resistance and some may have occurred during packaging for return to penumbra.The pusher assembly was not returned for evaluation.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 internal iliac artery (iia) using pod packing coils (packing coil), ruby coils, and a lantern delivery microcatheter (lantern).It should be noted that the patient¿s anatomy was mildly tortuous.During the procedure, the physician successfully implanted two ruby coils and one packing coil into the target vessel using the lantern.While attempting to advance another packing coil through the mid-shaft of the lantern, the packing coil became stuck within the lantern.While attempting to push and pull the packing coil within the lantern, it unintentionally detached.Therefore, the lantern containing the packing coil was removed.It was reported that the packing coil was flushed out of the lantern on the back table.The procedure was completed using a new packing coil and the same lantern.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: 19734278
• Report Number: 3005168196-2024-00246
• Device Sequence Number: 20863624
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 00814548017662
• 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): 07/12/2024
• 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: RBYPODJ45
• Device Lot Number: F00009250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2024
• 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: 06/21/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005