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

Model Number 4002C0935

Device Problem Break (1069)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient was undergoing a coil embolization procedure to treat an aneurysm off the posterior communicating artery (pca) using penumbra coils 400 (pc400s), a px slim delivery microcatheter (px slim), and benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician implanted five pc400s via the px slim.While advancing and adjusting the sixth pc400 in and out of the aneurysm to obtain a better position, the physician felt the pc400 break.The physician attempted to remove the pc400, but it was partially broken.Therefore, the broken piece of pc400 was removed together with the px slim and benchmark.The embolization was completed, and the procedure concluded.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned pc400 confirmed that the pusher assembly was fractured at its distal tip and revealed that the pusher assembly ddt was fractured off and the embolization was detached from the pusher assembly.If the device is forcefully manipulated against resistance during use, the pusher assembly ddt may become fractured off from the distal polymer of the pusher assembly.This damage will likely contribute to the embolization coil detaching from its pusher assembly.Further investigation of the device revealed kinks in the pusher assembly and offset coil winds in the embolization coil.This damage was incidental to the reported complaint may have occurred during packaging of the device for 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.H3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11668374
• MDR Text Key: 245492775
• Report Number: 3005168196-2021-00755
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010588
• UDI-Public: 00814548010588
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/19/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2024
• Device Model Number: 4002C0935
• Device Catalogue Number: 4002C0935
• Device Lot Number: F67457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR