MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject device (coil) was broken during withdrawal.Another product was inserted and then the procedure was completed.There were no reported clinical consequences to the patient due to this event.
Event or Problem Description
It was reported that the subject device (coil) was broken during withdrawal.Another product was inserted and then the procedure was completed.There were no reported clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection of the device revealed that the proximal contact was kinked, likely while handling the device either during the preparation for the procedure or during the clinical procedure.Additionally, the delivery wire was kinked and broken near the distal end; therefore; the functional test could not be performed on the returned device.In the case of this complaint it was reported that friction was met between the target coil and a microcatheter during the clinical procedure, and the coil was pulled back.It was also reported that the coil broke during withdrawal.As the main coil was not returned; however, the delivery wire was found to be broken and kinked near the distal end.These defects were most likely due to excessive force being applied to the device during withdrawal against friction.The reported friction was most likely due to some procedural factors encountered during use leading to the subsequent failures.Based on the investigation results and available information, an assignable cause of procedural factors - cause traced to component failure will be assigned to this investigation.The issue is associated with a product that meets stryker design and manufacture specifications and was used according to the device directions for use (dfu) but due to procedural and/or anatomical factors encountered during use, the device performance was limited.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection of the device revealed that the proximal contact was kinked, likely while handling the device either during the preparation for the procedure or during the clinical procedure.Additionally, the delivery wire was kinked and broken near the distal end; therefore; the functional test could not be performed on the returned device.In the case of this complaint it was reported that friction was met between the target coil and a microcatheter during the clinical procedure, and the coil was pulled back.It was also reported that the coil broke during withdrawal.As the main coil was not returned; however, the delivery wire was found to be broken and kinked near the distal end.These defects were most likely due to excessive force being applied to the device during withdrawal against friction.The reported friction was most likely due to some procedural factors encountered during use leading to the subsequent failures.Based on the investigation results and available information, an assignable cause of procedural factors - cause traced to component failure will be assigned to this investigation.The issue is associated with a product that meets stryker design and manufacture specifications and was used according to the device directions for use (dfu) but due to procedural and/or anatomical factors encountered during use, the device performance was limited.
Event or Problem Description
It was reported that the subject device (coil) was broken during withdrawal.Another product was inserted and then the procedure was completed.There were no reported clinical consequences to the patient due to this event.

• Brand Name: TARGET 360 SOFT 4MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7883139
• Report Number: 3008881809-2018-00404
• Device Sequence Number: 19455169
• Product Code: HCG
• UDI-Device Identifier: 04546540676481
• UDI-Public: 04546540676481
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: 09/30/2020
• Device Catalogue Number: M0035474150
• Device Lot Number: 20036890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY17 MICROCATHETER (TERUMO)