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

Model Number	RBYPOD5-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
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 the splenic artery using pod coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing a pod coil into the target vessel, the physician experienced resistance and the pod coil would not advance.Therefore, it was removed.The procedure was completed using a new pod coil and the same lantern.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod coil revealed offset coil winds.If the device is forcefully advanced against resistance, damage such as this may occur.Further evaluation revealed the introducer sheath was loaded backwards onto the pusher assembly.This damage was likely incidental to the reported complaint.During functional testing, the pod coil was re-sheathed properly into its introducer sheath.The pod coil was then able to advance through its introducer sheath and a demonstration lantern without an issue.The root cause of resistance during the procedure 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.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12276392
• Report Number: 3005168196-2021-01745
• Device Sequence Number: 17169049
• Product Code: HCG
• UDI-Device Identifier: 00814548019604
• UDI-Public: 00814548019604
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 08/04/2021
• 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: RBYPOD5-A
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F93979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Date Report Sent to FDA: 01/01/2005