MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035474080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During preparation, it was reported that the delivery wire of the coil was broken.The procedure was completed successfully after changing to another coil.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the delivery wire was kinked not broken.In addition, the proximal contact was kinked and broken.Based on the information currently available and the device inspection, it is likely that the damages on the proximal contact and delivery wire are due to handling of the device or portion of the device during the clinical procedure, upon removal of the device from the packaging, or preparation of the device prior to use.And the customer may perceive the proximal contact as the delivery wire, because those two parts are connected.Therefore the reported delivery wire broken was not confirmed.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
During preparation, it was reported that the delivery wire of the coil was broken.The procedure was completed successfully after changing to another coil.No clinical consequences reported to the patient.

• Brand Name: TARGET 360 SOFT 4MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6758988
• Report Number: 3008881809-2017-00232
• Device Sequence Number: 1566151
• Product Code: HCG
• UDI-Device Identifier: 04546540676467
• UDI-Public: (01)04546540676467(17)200229(10)19592195
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K102672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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: M0035474080
• Device Catalogue Number: M0035474080
• Device Lot Number: 19592195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR