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

Catalog Number	RBYPOD10
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	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the femoral artery using pod coils, a non-penumbra microcatheter, and a catheter.It should be noted that the patient''s anatomy was tortuous, calcified, and stenosed.During the procedure, the physician injected an embolic agent through a non-penumbra microcatheter before exchanging the microcatheter for a new one.While advancing the pod coil through the microcatheter, resistance was encountered.After the pod coil was advanced into the target location, the microcatheter slipped out of position.Resistance was encountered while retracting the pod coil and, subsequently, the microcatheter was re-positioned.The physician was preparing to re-advance the pod coil and noticed that the coil was unintentionally detached and contained inside the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed from the patient.The procedure was completed using non-penumbra coils, a new non-penumbra microcatheter, and more of the embolic agent.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned pod coil confirmed that the embolization coil was detached.Evaluation revealed that the pusher assembly was fractured, and the pull wire was retracted from the ddt.If the device is advanced against resistance, damage such as a kink and subsequent fracture on the pusher assembly may occur.This damage likely contributed to the unintentional detachment of the embolization coil.The resistance was likely due to the kink on the non-penumbra microcatheter which was used in the procedure.Further evaluation of the device revealed kinks on the pusher assembly.This damage was likely incidental to the complaint and likely occurred during packaging for the device return.Penumbra coils are visually 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: 14916817
• Report Number: 3005168196-2022-00320
• Device Sequence Number: 17714507
• Product Code: HCG
• UDI-Device Identifier: 00814548019659
• UDI-Public: 814548019659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022
• 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 Catalogue Number: RBYPOD10
• Device Lot Number: F109680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005