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

Model Number	M0035474150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned without the introducer sheath.Visual inspection of the device revealed that the proximal contact and main coil were kinked.The main coil was stretched and the coil delivery wire was broken.During functional testing, the coil was flushed, could not be advanced through the introducer sheath but it was able to be retracted.No other anomalies were noted on the device.Information available indicated that the device was confirmed to be in good condition prior to the use.It is possible that the reported coil delivery wire fractures occurred due to handling of the device or portion of the device during the clinical procedure.Therefore based on all of the information available an assignable cause of handling damage was assigned to this investigation.
Event or Problem Description
Analysis of the returned device noted that the coil delivery wire was broken.No consequences to the patient were reported.

• 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: 6983720
• Report Number: 3008881809-2017-00454
• Device Sequence Number: 18943548
• Product Code: HCG
• UDI-Device Identifier: 04546540676481
• UDI-Public: (01)04546540676481(17)191130(10)19432148
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/27/2017

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: 11/30/2019
• Device Model Number: M0035474150
• Device Catalogue Number: M0035474150
• Device Lot Number: 19432148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR