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

Catalog Number 4002C1040

Device Problems Physical Resistance/Sticking (4012); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

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of the returned pc400 confirmed that the embolization coil was detached.Evaluation revealed that the pull wire was retracted out of its initial position and extended distally beyond the tip of the pusher assembly.If the pc400 is retracted against resistance, the pusher assembly may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
• Type of Device: 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
• MDR Text Key: 334882970
• Report Number: 3005168196-2024-00040
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male