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

Model Number	4002C0935
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem 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.
Additional 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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11668374
• Report Number: 3005168196-2021-00755
• Device Sequence Number: 2980569
• Product Code: HCG
• UDI-Device Identifier: 00814548010588
• UDI-Public: 00814548010588
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021
• 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 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005