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

Model Number	RBYPOD4-A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 in multiple tibial developmental venous anomaly (dva) collateral vessels using pod coils and a lantern delivery microcatheter (lantern).During the procedure, the physician delivered six coils to the target locations.While delivering the next pod coil, the physician realized there was not enough landing zone to fully deploy the pod coil and opted to retract it.The pod coil stopped tracking halfway through the introducer sheath.Another attempt was made again to retract the pod coil into the introducer sheath; however, the hospital tech bent the pusher assembly.This caused the pod coil and introducer sheath to stay stuck in their position.Since the physician had opted to recapture prior to complication, they removed the pod coil out of introducer sheath.The procedure was completed using two new coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod4 confirmed a kinked pusher assembly.This damage was likely a result of improper handling of the device during use.If the pusher assembly is forcefully mishandled at an extreme angle during use, damage such as this may occur.Further evaluation of the device revealed that the pusher assembly was fractured, the embolization coil was detached from the pusher assembly and had offset coil winds, and the introducer sheath was stretched and kinked.These damages were not indicated in the complaint; therefore, these damages were incidental to the complaint and may have occurred during packaging for return to penumbra.Due to the returned damage, the device was unable to be functionally tested.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.H3 other text : placeholder.

• Brand Name: POD 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: 12583578
• Report Number: 3005168196-2021-02208
• Device Sequence Number: 3289291
• Product Code: HCG
• UDI-Device Identifier: 00814548019598
• UDI-Public: 00814548019598
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021
• 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: F106626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• 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: 09/11/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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 Age: 47 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005