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

Model Number	4006C0404
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is not available for return.A follow up mdr will be submitted upon completion of the device manufacturing records.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 (pc400) and a px slim delivery microcatheter (px slim).During the procedure, a pc400 became stuck in the px slim while advancing it towards the target vessel.Therefore, the pc400 was removed.The procedure was completed using a new smart coil and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Correction: please note that the following section is being updated based on additional information provided by a penumbra sales representative on 05/30/2021: 1.Section b.Box 5.Describe event or problem.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra coil 400 (pc400) and a px slim delivery microcatheter (px slim).During the procedure, seven coils were implanted successfully in the target location using the px slim.While attempting to implant the eighth coil, the physician encountered resistance while advancing the pc400 through the px slim.When the distal part of the pc400 was advanced out of the px slim, the pc400 became stuck.The physician released slack on the px slim; however, the pc400 still could not be pushed out.Therefore, the pc400 was removed.The procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11867000
• Report Number: 3005168196-2021-01129
• Device Sequence Number: 3508236
• Product Code: HCG
• UDI-Device Identifier: 00814548011882
• UDI-Public: 00814548011882
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020
• 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: 04/15/2021
• Device Model Number: 4006C0404
• Device Catalogue Number: 4006C0404
• Device Lot Number: A34639
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Date Report Sent to FDA: 01/01/2005