MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 24MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036182450
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during the coil embolization, there was difficulty positioning the subject coil in the aneurysm.Therefore the physician attempted to pull the subject coil out of the patient.While retracing, the subject coil was prematurely detached inside the microcatheter.The physician removed the microcatheter and the coil as one unit.There were no 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 there was no damage noted to the device prior to use and the device was prepared as per device directions for use (dfu).However, the information also indicated that the coil was repositioned during procedure and the device dfu states that coil should be repositioned only if necessary as it can cause damage to coil, possibly leading to the reported premature detachment.Based on the information provided, the reported coil premature detachment during use is most likely related to some procedural factors which limited the performance of the device.Therefore, it was determined that the reported event was related to operational context.
Event or Problem Description
It was reported that during the coil embolization, there was difficulty positioning the subject coil in the aneurysm.Therefore the physician attempted to pull the subject coil out of the patient.While retracing, the subject coil was prematurely detached inside the microcatheter.The physician removed the microcatheter and the coil as one unit.There were no clinical consequences to the patient.

• Brand Name: TARGET XXL 360 24MM 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: 6309488
• Report Number: 3008881809-2017-00033
• Device Sequence Number: 10954680
• Product Code: HCG
• UDI-Device Identifier: 07613327128376
• UDI-Public: 0107613327128376171910311019382037
• 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): 04/28/2017

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: M0036182450
• Device Lot Number: 19382037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR MICROCATHETER (STRYKER)