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

Model Number	4004C0715
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
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 using penumbra coil 400 (pc400).During the procedure, a pc400 would not advance at all within its introducer sheath; therefore, it was removed.The procedure was completed using a new pc400.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 01/29/2020: section b.Box 5.Describe event or problem.It was previously understood that the issue occurred while in use in the patient.However, based on the updated information, the issue occurred during preparation.Note: although the event summary alleged a deterioration in the characteristics or performance of the device, this event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.Therefore, this is not considered a reportable event.
Event or Problem Description
During preparation for a coil embolization procedure, the penumbra coil 400 (pc400) would not advance at all from its initial position within its introducer sheath on the back table.The issue with the pc400 was found prior to use, therefore, the pc400 was not used in the procedure.The procedure was completed using another pc400.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the follow-up #01 and is being included on this follow-up #02: 3005168196-2020-00117.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9644057
• Report Number: 3005168196-2020-00117
• Device Sequence Number: 1965421
• Product Code: HCG
• UDI-Device Identifier: 00814548010908
• UDI-Public: 00814548010908
• 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,Followup
• Report Date (Section B): 01/08/2020
• 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: 08/15/2026
• Device Model Number: 4004C0715
• Device Catalogue Number: 4004C0715
• Device Lot Number: C16208
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/29/2020; 01/14/2005
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/21/2020; 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Date Report Sent to FDA: 01/01/2005