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

Catalog Number M0035425100

Device Problem Premature Activation (1484)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 02/16/2017

Event Type  Injury  

Event 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.

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 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
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: michael reddick ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6412024
• MDR Text Key: 70170546
• Report Number: 3008881809-2017-00078
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540675958
• UDI-Public: (01)04546540675958(17)180930(10)18601489
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention