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

Model Number	RBYPOD4-A
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod coil revealed a fractured pusher assembly.If the device is mishandled at extreme angle during advancement, damage such as a kink and subsequent fracture may occur.Further evaluation of the device revealed that the pe fibers were fractured, and the embolization coil was detached from the pusher assembly.If the device is forcefully retracted against resistance, damage such as a pe fibers fracture may occur and subsequently the embolization coil may detach from the pusher assembly.The root cause of the resistance could not be determined.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a varicocele using pod coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing the pod coil into the lantern, the radiology technician noticed a kink on the pusher assembly of the pod coil.The radiology technician then attempted to slowly advance the pod coil; however, the kink became worse.Therefore, it was decided to remove the pod coil.Upon retraction, it was noticed that the pod coil was detached from its pusher assembly.The physician was able to pull the detached pod coil from the rotating hemostasis valve (rhv) by hand.The procedure was completed using a new pod coil and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12169673
• Report Number: 3005168196-2021-01534
• Device Sequence Number: 4198660
• Product Code: HCG
• UDI-Device Identifier: 00814548019598
• UDI-Public: 00814548019598
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2021
• 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 Model Number: RBYPOD4-A
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F105119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• 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: 06/15/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Date Report Sent to FDA: 01/01/2005