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

Model Number	4006C0308
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
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 in the basilar artery using penumbra coils 400 (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the third coil, a pc400, was unable to be advanced into the px slim and resistance was noted.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.
Additional Manufacturer Narrative
Evaluation of the returned pc400 was unable to confirm the reported complaint.The returned embolization coil was detached from the pusher assembly; therefore, it could not be tested for the reported difficulty advancing.Evaluation also revealed that the proximal end of the pusher assembly was stuck inside the returned handle, the embolization coil had offset coil winds, and the pusher assembly was kinked in multiple locations throughout its length.This damage was incidental to the reported complaint.Evaluation of the returned handle revealed that the proximal end of the returned pc400 pusher assembly was stuck inside.This damage was incidental to the reported complaint.Based on the reported event, it is unknown why the coil would have been detached with the handle if it was unable to advance through the microcatheter.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually inspected and functionally tested during incoming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11806691
• Report Number: 3005168196-2021-01012
• Device Sequence Number: 3646415
• Product Code: HCG
• UDI-Device Identifier: 00814548011851
• UDI-Public: 00814548011851
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 04/16/2021
• 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 Model Number: 4006C0308
• Device Catalogue Number: 4006C0308
• Device Lot Number: F90519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005