MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4002C1040
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	12/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using penumbra coil 400s (pc400s) and a non-penumbra microcatheter.During the procedure, the physician experienced resistance while advancing a pc400 into the target location.The physician continued to experience resistance while advancing the pc400 into the target location and decided to remove the pc400.While attempting to remove the pc400, only the pusher assembly came out and the physician noticed that the pc400 had unintentionally detached in the middle of the microcatheter.Therefore, the microcatheter containing the detached pc400 was slowly removed from the patient.The pc400 was then removed from the microcatheter.The procedure was completed using a new pc400 and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned pc400 confirmed that the embolization coil was detached.Evaluation revealed that the pull wire was retracted out of its initial position and extended distally beyond the tip of the pusher assembly.If the pc400 is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire, and the embolization coil may detach from the pusher assembly.Further evaluation revealed that the pet lock was separated, the pull wire was kinked near its proximal end and the embolization coil had offset coil winds.This damage was incidental to the reported complaint and likely occurred during packaging for return to penumbra.Some of the offset coil winds on the embolization coil may have occurred due to advancement against resistance during the procedure.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: PENUMBRA COIL 400
• 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: 18643716
• Report Number: 3005168196-2024-00040
• Device Sequence Number: 20833549
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 814548010601
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120330
• 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): 03/27/2024
• 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: 4002C1040
• Device Lot Number: F110899
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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 Age: 27 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005