MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181450
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during embolization procedure the resistance was encountered and the coil was prematurely detached inside the microcatheter when attempted to be re-sheathed.The coil along with the microcatheter was safely removed from the patient as one unit.There were no clinical consequences to the patient due to this event.
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 the device was confirmed to be in good condition prior to use.Based on the information currently available the exact cause for the reported issue cannot be determined.
Event or Problem Description
It was reported that during embolization procedure the resistance was encountered and the coil was prematurely detached inside the microcatheter when attempted to be re-sheathed.The coil along with the microcatheter was safely removed from the patient as one unit.There were no clinical consequences to the patient due to this event.

• Brand Name: TARGET XXL 360 14MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6502235
• Report Number: 3008881809-2017-00114
• Device Sequence Number: 1628041
• Product Code: HCG
• UDI-Device Identifier: 07613327128383
• UDI-Public: 07613327128383
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• 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): 06/20/2017

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: 10/31/2019
• Device Catalogue Number: M0036181450
• Device Lot Number: 19393736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1