MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH SYNCHRO 2/14 200 CM STANDARD; WIRE, GUIDE, CATHETER

Catalog Number M00326410

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Vascular Dissection (3160)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that a minimal no flow limiting dissection occurred while performing a triaxial technique to stent a large right cavernous ica aneurysm.Although the procedure was successfully completed, the physician believed that the competitor microcatheter may have contributed to the dissection, but it was "difficult to say absolutely".During follow up at 28 days post the index procedure, the patient was reported to be experiencing blurry vision and the physician believed that it may be related to some microemboli shed possibly related to the guidewire.No further information is available.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, vessel dissection, embolus and neurological sequelae are known risk associated with endovascular procedures and are listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.

Event Description

It was reported that a minimal no flow limiting dissection occurred while performing a triaxial technique to stent a large right cavernous ica aneurysm.Although the procedure was successfully completed, the physician believed that the competitor microcatheter may have contributed to the dissection, but it was "difficult to say absolutely." during follow up at 28 days post the index procedure, the patient was reported to be experiencing blurry vision and the physician believed that it may be related to some microemboli shed possibly related to the guidewire.No further information is available.

• Brand Name: SYNCHRO 2/14 200 CM STANDARD
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH; 2405 orion circle; west valley city UT 84119
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH; 2405 orion circle; west valley city UT 84119
• Manufacturer Contact: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5474769
• MDR Text Key: 39518915
• Report Number: 3008853977-2016-00081
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053268
• 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: 02/04/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: M00326410
• Device Lot Number: B36551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 03/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2015
• 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
• Patient Age: 53 YR