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

Model Number	RBYPOD12-A
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	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod coil confirmed that the embolization coil was detached from the pusher assembly and revealed that the pusher assembly was fractured and kinked near the fractured location.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further manipulation of a kinked device may result in a fracture.The pusher assembly fracture likely contributed to the embolization coil detaching during the procedure.Due to the pusher assembly fracture, functional testing was unable to be performed; therefore, the root cause of the resistance experienced during the procedure could not be determined.Further evaluation of the device revealed additional kinks in the pusher assembly.This damage was likely incidental to the complaint.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 in the portal vein using ruby coils, pod coils, packing coils, and a non-penumbra microcatheter.During the procedure, the physician was coiling separate branches off the portal vein and successfully implanted five penumbra coils within various branches.Subsequently, when advancing the sixth coil, a pod coil, through the microcatheter, the physician encountered resistance.The physician then attempted to pull the pod coil out and realized the pod coil had unintentionally detached in the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed, and the pod coil was flushed out of the microcatheter with a syringe of heparinized saline.The procedure was completed using a new pod coil, packing coil, and the same microcatheter.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: 11786571
• Report Number: 3005168196-2021-00974
• Device Sequence Number: 3646590
• Product Code: HCG
• UDI-Device Identifier: 00814548019666
• UDI-Public: 00814548019666
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2021
• 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: RBYPOD12-A
• Device Catalogue Number: RBYPOD12
• Device Lot Number: F100853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• 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: 04/08/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005