MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035452040
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the coil detached prematurely during the procedure.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Product available to stryker ¿ updated.Returned to manufacturer on ¿updated.Device evaluated by mfg ¿updated.The device history record review confirms that the device met all material, assembly and performance specifications.The device was returned without its introducer sheath visual inspection revealed that the coil delivery wire was kinked, likely due to handling.The main coil was found to be kinked and stretched as well.No other anomalies were noted on the device.The physician may have perceived the observed damages (stretch) as detachment and reported it as such; however, no coil detachment was identified on the device.The reported coil premature detachment could not be confirmed during analysis.Functional evaluation could not be performed due to the damage noted to the device.Based on the device analysis, the reported coil premature detachment 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
It was reported that the coil detached prematurely during the procedure.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Manufacturing date ¿ added.Expiration date - added.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The cause of the reported issue could not be definitively determined.
Event or Problem Description
It was reported that the coil detached prematurely during the procedure.There were no reported clinical consequences to the patient.

• Brand Name: TARGET HELICAL NANO 2 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6918907
• Report Number: 3008881809-2017-00394
• Device Sequence Number: 13762846
• Product Code: HCG
• UDI-Device Identifier: 07613252600374
• UDI-Public: (01)07613252600374(17)190731(10)19208584
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2018

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: 07/31/2019
• Device Model Number: M0035452040
• Device Catalogue Number: M0035452040
• Device Lot Number: 19208584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 11/09/2017; 12/18/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 12/05/2017; 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1