MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035475200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the proximal part of the coil delivery wire broke when it was being taking out from the introducer sheath.There were no patient complications reported due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Visual inspection revealed that the proximal contact was intact.The delivery wire was found broken/fractured below the proximal contact bond, and the delivery wire was found slightly kinked.The main coil was found kinked near the detachment zone.The exact cause for the main coil kink cannot be determined as this was not reported by the customer.In addition, information available indicated that the coil was being taken out of the introducer sheath when the break on the delivery wire was observed.Therefore, based on the information available and damages observed to the delivery wire, an assignable cause of handling damage has been assigned to this investigation.
Event or Problem Description
It was reported that the proximal part of the coil delivery wire broke when it was being taking out from the introducer sheath.There were no patient complications reported due to this event.

• Brand Name: TARGET 360 SOFT 5MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6906168
• Report Number: 3008881809-2017-00390
• Device Sequence Number: 1324184
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: (01)04546540676511(17)200229(10)19563524
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K112385
• 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): 11/29/2017

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: 02/29/2020
• Device Model Number: M0035475200
• Device Catalogue Number: M0035475200
• Device Lot Number: 19563524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 11/05/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1