MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035425100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Date of Event	02/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician experienced friction while trying to repositioned the coil.It was reported that the coil was repositioned approximately 3 to 4 times when it detached.The physician proceeded to cut the hub of the microcatheter in attempt to remove the coil; however, the coil became jammed in the microcatheter; therefore, the physician removed the microcatheter along with the coil.There was a surgical delay, and the patient's blood pressure dropped several times and the patient lost one liter of blood.It was reported that there was no residual effect on the patient due to this event.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the device revealed that the main coil was physically broken off the delivery wire below the main junction, and the coil suture was broken.In addition, the delivery wire was kinked/bent likely due to handling.Blood residue was noted on the returned coil which could indicate insufficient flush; this however cannot be conclusively determined because it was indicated that flush was used during procedure.The break observed at the main junction was likely due to excessive force used reposition of the device limiting its performance during use.Therefore, it was determined that the reported event was related to operational context.The patient hemorrhage is a known risk associated with endovascular procedures and is noted as such in the device directions for use (dfu) and anticipated in nature.
Event or Problem Description
The physician experienced friction while trying to reposition the coil.It was reported that the coil was repositioned approximately 3 to 4 times when it detached.The physician proceeded to cut the hub of the microcatheter in attempt to remove the coil; however, the coil became jammed in the microcatheter; therefore, the physician removed the microcatheter along with the coil.There was a surgical delay, and the patient's blood pressure dropped several times and the patient lost one liter of blood.It was reported that there was no residual effect on the patient due to this event.

• Brand Name: TARGET 360 ULTRA 5MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6412024
• Report Number: 3008881809-2017-00078
• Device Sequence Number: 13682741
• Product Code: HCG
• UDI-Device Identifier: 04546540675958
• UDI-Public: (01)04546540675958(17)180930(10)18601489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102672
• 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): 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: M0035425100
• Device Lot Number: 18601489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention