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

Catalog Number	RBYPOD5
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	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a pod coil, a non-penumbra microcatheter, and an angiographic catheter.It was noted that the patient¿s anatomy was moderately tortuous.During the procedure, the physician advanced the pod coil into the target vessel using the microcatheter.However, the pod coil was not taking it¿s intended shape.After multiple attempts to retract and re-advance the pod coil against resistance, the physician felt and noticed under angiogram that the pod coil had unintentionally detached within the microcatheter.Therefore, the microcatheter containing the pod coil was removed.The procedure was competed using a new pod coil.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embolization coil was detached.Evaluation revealed, that the pusher assembly was kinked and fractured.And the pull wire was retracted out of the distal tip of the pusher assembly.If the pod coil is manipulated against resistance, during use, damage such as a kink and subsequent fracture may occur.Separation of the two fractured segment will result in the pull wire retracting from the distal tip of the pusher assembly and the embolization coil detaching.The patient¿s tortuous anatomy may have contributed to resistance, during the procedure.The embolization coil was not returned for evaluation.Further evaluation revealed, additional kinks along the length of the pusher assembly.This damage was incidental to the reported complaint and may have occurred, during packaging for 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.
Additional Manufacturer Narrative
Please note that the following sections were inadvertently missed on the follow-up #01 and are being updated on this follow-up #02 mfr report: 3005168196-2023-00266.Section h.Box 3.Device evaluated by manufacturer/device returned to manufacturer/evaluation summary.

• 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: 17065444
• Report Number: 3005168196-2023-00266
• Device Sequence Number: 6679693
• Product Code: HCG
• UDI-Device Identifier: 00814548019604
• UDI-Public: 814548019604
• 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,Followup
• Report Date (Section B): 06/21/2023
• 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: RBYPOD5
• Device Lot Number: F110619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/21/2023; 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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: Male
• Date Report Sent to FDA: 01/01/2005