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

Catalog Number DH1

Device Problems Contamination (1120); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2018-00850, 3005168196-2018-00851.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure for a vessel sacrifice using penumbra coils 400 (pc400¿s) and a penumbra coil 400 detachment handle (handle).During the procedure, while advancing a pc400 through a px slim delivery microcatheter (px slim), the hospital fellow was too aggressive and inadvertently bent the pc400 pusher assembly; therefore, it was removed.It was reported that another pc400 pusher assembly was also bent while advancing the pc400 through the px slim; therefore, it was removed.The procedure continued using additional coils.Around the 30th coil, it was reported that blood might have gotten inside the handle and its the trigger became a bit sticky; therefore, the handle was set aside.The procedure was completed using the same px slim, a new handle and additional pc400's.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400 DETACHMENT HANDLE
• 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: 7461696
• MDR Text Key: 106609547
• Report Number: 3005168196-2018-00852
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548011974
• UDI-Public: 00814548011974
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/27/2019
• Device Catalogue Number: DH1
• Device Lot Number: F70311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• 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: 39 YR