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	05/28/2021
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 number: 3005168196-2021-01435.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the subclavian artery using pod coils, and a lantern delivery microcatheter (lantern).During the procedure, while advancing a pod coil through a lantern the physician experienced resistance and decided to retract the pod coil.Upon retraction, it was noticed that the pod coil had unintentionally detached inside the lantern.Therefore, the physician removed the lantern containing the detached pod coil and then flushed the pod coil.It was also reported that the pusher assembly of the pod coil had become kinked.Afterwards, the physician experienced resistance while advancing the second pod coil through the same lantern; however, the pod coil was successfully placed in the target location.The procedure was completed using two pod packing coils (pod pcs) and the same lantern.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: 12087326
• Report Number: 3005168196-2021-01434
• Device Sequence Number: 14328341
• Product Code: HCG
• UDI-Device Identifier: 00814548019666
• UDI-Public: 00814548019666
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2021
• 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 Expiration Date: 09/02/2026
• Device Model Number: RBYPOD12-A
• Device Catalogue Number: RBYPOD12
• Device Lot Number: F85649
• 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: 06/01/2021
• Initial Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005