MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036101040
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2017
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, resistance was experienced as the coil was being advanced through the microcatheter.The physician pull back the coil and only the delivery wire came out.The coil was stuck inside the microcatheter.The coil and microcatheter were removed from patient¿s body without any clinical consequences to the patient.
Additional Manufacturer Narrative
A review of the device history record confirmed that the device met all material, assembly and performance specifications.The device was returned in its introducer sheath and dispenser hoop along with the microcatheter associated.The delivery wire and introducer sheath were found to be kinked likely due to handling.Functional testing could not be performed as the coil was detached from the delivery wire.The main coil was noted to be in the micro catheter when a patency test was performed and it was noted that there was an object blocking the patency mandrel.The catheter was cut and the coil sustained stretching and damage to the distal end but was able to be removed.There was a significant amount of procedural fluid (blood) on the coil when removed from the catheter.The delivery wire was kinked and is suggestive of resistance during the procedure.It is likely that backflow of blood occurred and that the coil broke from the delivery wire at the main junction due to resistance experienced.Information available indicated that the device was confirmed to be in good condition prior to use.It is likely that the break as well as damages observed to the main coil were due to some procedural/anatomical factor limiting its performance.Based on the investigation results and available information an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
It was reported that during the coil embolization, resistance was experienced as the coil was being advanced through the microcatheter.The physician pull back the coil and only the delivery wire came out.The coil was stuck inside the microcatheter.The coil and microcatheter were removed from patient¿s body without any clinical consequences to the patient.

• Brand Name: TARGET XL 360 STANDARD 10MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6478563
• Report Number: 3008881809-2017-00102
• Device Sequence Number: 655148
• Product Code: HCG
• UDI-Device Identifier: 04546540711274
• UDI-Public: (01)04546540711274(17)190630(10)19138997
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

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: 06/30/2017
• Device Model Number: M0036101040
• Device Catalogue Number: M0036101040
• Device Lot Number: 19138997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 08/18/2017
• 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: SL-10 MICROCATHETER (STRYKER)