MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 9CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036123090
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
The physician unsuccessfully repositioned the coil several time; therefore, it was removed.It was reported that when the coil was being removed it became stuck in the y-connector valve and it detached.There was no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Information available indicated that ¿although the coil was repositioned several times in the aneurysm of ic, it was not able to deploy nicely.¿ it is probable that the device became damaged as a result of the repositioning attempts resulting in the reported event.An assignable cause of operation context has been assigned to this event.
Event or Problem Description
The physician unsuccessfully repositioned the coil several times; therefore, it was removed.It was reported that when the coil was being removed it became stuck in the y-connector valve and it detached.There was no reported clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 3MM X 9CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5723126
• Report Number: 3008881809-2016-00031
• Device Sequence Number: 18994377
• Product Code: HCG
• UDI-Device Identifier: 07613327128284
• UDI-Public: (01)07613327128284(17)190331(10)18911099
• Combination Product (Y/N): N
• PMA/510(K) Number: K123377
• 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,Followup
• Report Date (Section B): 05/18/2016

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: 03/31/2019
• Device Catalogue Number: M0036123090
• Device Lot Number: 18911099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2016
• Supplement Report FDA Received Date: 08/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1