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

Model Number	RBYPOD8
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	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device 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 in the subclavian artery using a pod coil and a non-penumbra microcatheter.During the procedure, while advancing the pod coil through the microcatheter, the physician experienced resistance and decided to retract the pod coil.Upon retraction, the pod coil unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed and the pod coil was flushed out.The procedure was completed using a ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod8 confirmed that the embolization coil was detached from its pusher assembly.If the device is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire.If this occurs, the embolization will detach from the pusher assembly.Further evaluation of the device revealed that the sr wire was fractured.This damage was likely incidental to the complaint and the root cause could not be determined.Evaluation also revealed that the embolization coil had offset coil winds and the pusher assembly was kinked.Some of the offset coil winds likely occurred due to forceful advancement against resistance during the procedure and some of them were likely occurred due to the sr wire fracture.The kinks on the pusher assembly were incidental to the reported complaint and likely occurred during packaging for the device return.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12339804
• Report Number: 3005168196-2021-01832
• Device Sequence Number: 17388618
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022
• 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: F102621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/28/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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: 76 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005