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

Catalog Number	4004C0720
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2016
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 in the ophthalmic artery using penumbra coil 400's (pc400's).During the procedure, the physician successfully placed fifteen pc400's into the target vessel using a px slim delivery microcatheter (px slim).After deploying a new pc400 about half way into the aneurysm using the px slim, the physician noticed that the coil was not advancing or retracting when pushing and pulling on the pusher assembly.The physician then realized that the pc400 had unintentionally detached.Therefore, the px slim was removed with the pc400 inside.The physician did not mention experiencing any resistance while advancing or retracting the pc400.The procedure was then successfully completed using another manufacturer's microcatheter and coils.It should be noted that the physician maintained a continuous flush and used a rotating hemostasis valve (rhv) throughout the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report: expiration date.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5958029
• Report Number: 3005168196-2016-01331
• Device Sequence Number: 1451327
• Product Code: HCG
• UDI-Device Identifier: 00814548010915
• UDI-Public: 00814548010915
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 08/19/2016
• 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: Physician
• Device Expiration Date: 10/04/2022
• Device Catalogue Number: 4004C0720
• Device Lot Number: F60899
• 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: 08/19/2016
• Supplement Date Received by Manufacturer: 09/19/2017; 01/14/2005
• Initial Report FDA Received Date: 09/16/2016
• Supplement Report FDA Received Date: 10/19/2017; 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Date Report Sent to FDA: 01/01/2005