MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035443060
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during the coil embolization procedure, the coil prematurely detached within the microcatheter.No consequences to the patient were reported.
Additional Manufacturer Narrative
While there are no indications, based on dhr review, that the device failed to meet its material, assembly, labeling, packaging, or performance specifications when released, a manufacturing defect was identified during the course of the investigation that caused the device to fail to perform as expected.The device was returned within the dispenser hoop and the introducer sheath was not returned.Visual examination of the returned device revealed that the proximal contact and the delivery wire were kinked likely due to handling damage.It was also found that the main coil was broken/ fractured from the etch link (the main coil was not returned).The suture was noted to be melted at approx.8mm from the etch link.Analysis of the suture revealed a ball like anomaly which likely originated in manufacturing.It is likely that the suture defect contributed to the main coil break/ detachment.Because this is an issue in which product fails to meet specification due to the manufacturing process at a stryker neurovascular manufacturing site, an assignable cause of manufacturing will be assigned to the reported main coil prematurely detached/separated inside patient, to the analyzed main coil broken, and main coil suture damage.
Event or Problem Description
It was reported that during the coil embolization procedure, the coil prematurely detached within the microcatheter.No consequences to the patient were reported.
Additional Manufacturer Narrative
Correction/removal rpt number: the reference number previously provided was incorrect.
Event or Problem Description
It was reported that during the coil embolization procedure, the coil prematurely detached within the microcatheter.No consequences to the patient were reported.

• Brand Name: TARGET 360 NANO 3 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5755583
• Report Number: 3008881809-2016-00051
• Device Sequence Number: 190919
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: (01)07613252600329(17)190228(10)18883033
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K113412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2016

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: 02/28/2019
• Device Catalogue Number: M0035443060
• Device Lot Number: 18883033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/31/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/28/2016
• Supplement Report FDA Received Date: 11/04/2016; 12/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 06/06/16-001-R
• Patient Sequence Number: 1