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

Model Number	RBYPOD8
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was implanted into the patient; however, the pusher assembly is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat varicose veins using pod coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing the pod coil through the lantern, the pod coil unintentionally detached.However, the physician was able to implant the pod coil into the target vessel by flushing the lantern and using the pusher assembly.The procedure was completed using a new pod coil and the same lantern.There was no report of an adverse affect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod coil pusher assembly confirmed that the embolization coil was detached and not returned.Further evaluation revealed that the pusher assembly was fractured and the pull wire was retracted out of the distal fractured segment.If the pod coil is advanced against resistance, damage such as a kink may occur.Further manipulation of a kinked device may worsen to a fracture.If the two fractured segments are separated and the pull wire is retracted out of the distal detachment tip (ddt), the embolization coil will detach from its pusher assembly.The root cause of resistance could not be determined.Further evaluation revealed addition kinks throughout the length of the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging for return.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.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12264523
• Report Number: 3005168196-2021-01725
• Device Sequence Number: 4440934
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021
• 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: RBYPOD8
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F93635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005