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

Model Number	RBYPOD14-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2021-00633, 3005168196-2021-00635.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right hypogastric artery using pod packing coils (pod pcs), pod coils, and a lantern delivery microcatheter (lantern).During the procedure, a pod pc was advanced into the target vessel and subsequently retracted for re-positioning when it detached inside the lantern.Therefore, the lantern containing the detached pod pc was removed from the patient and the pod pc was subsequently removed.While advancing a pod coil pusher wire through its introducer sheath, the pusher wire became kinked.Therefore, the pod coil was no longer used in the procedure.Next, the same issue occurred with another pod coil; therefore, this pod coil was no longer used in the procedure.The procedure was completed using additional pod pcs and pod coils.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: 11586918
• Report Number: 3005168196-2021-00634
• Device Sequence Number: 11957421
• Product Code: HCG
• UDI-Device Identifier: 00814548019673
• UDI-Public: 00814548019673
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 03/01/2021
• 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: RBYPOD14-A
• Device Catalogue Number: RBYPOD14
• Device Lot Number: F99110
• Was Device Available for Evaluation?: No
• 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: 03/01/2021
• Initial Report FDA Received Date: 03/29/2021
• 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