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

Catalog Number	RBYPOD6
Medical Device Problem Codes	Failure to Fold (1255); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod coil confirmed that the embolization coil was detached.Evaluation revealed that the pull wire was within the pusher assembly distal tip.If the pod coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and allow the embolization coil to detach from the pusher assembly.The resistance was likely due to the tortuous patient¿s anatomy as mentioned in the complaint.Further evaluation of the device revealed kinks on the pusher assembly and offset coil winds on the embolization coil.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.
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, resistance was encountered while advancing the first pod coil in the middle of the microcatheter; however, the physician continued to advance the pod coil against resistance.After the pod coil was advanced into the target location, it was reported that the pod coil did not take its intended shape.While removing the pod coil, resistance was encountered and, subsequently, the pod coil unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed.The procedure was completed using a new microcatheter to implant a total of thirteen ruby coils and pod coils.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16090493
• Report Number: 3005168196-2022-00615
• Device Sequence Number: 15136973
• 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
• Report Date (Section B): 01/03/2023
• 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: 12/27/2022
• 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: 12/08/2022
• Initial Report FDA Received Date: 01/03/2023
• 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