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

Catalog Number	M0035475200
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Subject device is not available.
Event or Problem Description
It was reported that when opening the package, the subject coil was stretched and broken.The procedure was completed successfully.There was no patient involvement.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual and microscopic examination of the returned device revealed that the delivery wire was kinked, and the main coil was kinked and stretched most likely due to handling damage.The coil was noted to be stretched but not broken.Friction was encountered while advancing the coil through the introducer sheath.Based on analysis of the device, the reported main coil break was not confirmed.Therefore, an assignable cause of "unable to confirm the complaint" has been assigned to this investigation.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
It was reported that when opening the package, the subject coil was stretched and broken.The procedure was completed successfully.There was no patient involvement.

• 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: 5665394
• Report Number: 3008881809-2016-00004
• Device Sequence Number: 23636
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: (01)04546540676511(17)180930(10)18621829
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2016

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: 09/30/2018
• Device Catalogue Number: M0035475200
• Device Lot Number: 18621829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 06/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1