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

Catalog Number	RBYPOD6
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	09/16/2022
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 lumbar artery using pod coils and a lantern delivery microcatheter (lantern).It should be noted that the patient''s anatomy was tortuous and calcified.During the procedure, the physician encountered resistance while advancing the first pod coil through the middle of the lantern and the coil became stuck.While attempting to remove the pod coil, it unintentionally detached.Therefore, the lantern containing the detached pod coil was removed from the patient and the coil was flushed out on the back table.The procedure was completed using another pod coil, three other coils, and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was wrinkled and slipped off the proximal end of the pusher assembly.If the pod coil is manipulated at the pet lock against resistance during use, the pet lock may become wrinkled and slip off the pusher assembly.This damage likely contributed to the embolization coil detachment during the procedure.The root cause of the resistance could not be determined.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• 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: 15615076
• Report Number: 3005168196-2022-00478
• Device Sequence Number: 5983309
• Product Code: HCG
• UDI-Device Identifier: 00814548019611
• UDI-Public: 814548019611
• 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): 10/31/2022
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: RBYPOD6
• Device Lot Number: F92274
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2019
• 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: Male
• Date Report Sent to FDA: 01/01/2005