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	11/21/2022
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 internal iliac artery (iia) using pod coils, a non-penumbra microcatheter, and an angiographic catheter.It should be noted that the patient's anatomy was tortuous and calcified.During the procedure, the physician encountered resistance while advancing a pod coil in the middle of the microcatheter and the coil became stuck.Upon retraction, resistance was also encountered and, subsequently, the pod coil unintentionally detached inside the middle of the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed and the pod coil was flushed out on the back table.The procedure was completed using the same microcatheter to successfully implant seven ruby coils into the target location, and a stent-graft was also used.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 its pusher assembly.Evaluation revealed that the pet lock was intact, and the pull wire was within its original position.If the pod coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire, and result in the embolization coil detaching from the pusher assembly.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed kinks throughout the length of the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra products 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: 15998754
• Report Number: 3005168196-2022-00577
• Device Sequence Number: 6737991
• 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): 12/21/2022
• 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: RBYPOD6
• Device Lot Number: F00002107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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