MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO .014GUIDE WIRE 35 CM TIP; WIRE, GUIDE, CATHETER

Catalog Number M00313010

Device Problem Flaked (1246)

Patient Problem No Patient Involvement (2645)

Event Date 08/12/2018

Event Type  malfunction  

Manufacturer Narrative

Subject devixe is not available.

Event Description

It was reported that prior to procedure, the polytetrafluoroethylene (ptfe) coating at the proximal portion of the guidewire (subject device) was flacking off.There was no patient involvement.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The synchro -14 guidewire was returned; the microcatheter and the torque device were not returned.Visual examination of the returned device revealed that the polytetrafluoroethylene (ptfe) coating was peeled/scrapped off on several places along its approximately 56.0cm section from proximal end.Additionally, peeling was observed on several other places along its length.The ptfe was scrapped on around 360 degree on few places.The ptfe coating was compressed on several places.It appears to be compressed with torque device brass collet.The ptfe coating appeared to be scraped off from the guidewire with the torque device brass collet and/or the introducer.It was also observed that the guidewire was slightly bent between nitinol and ptfe coating likely due to handling of the guidewire during packing prior to shipping.During functional testing, the section of the guidewire where the ptfe coating did not show any peeling was tested to ensure acceptable adhesion by wrapping the guidewire around a 0.142" mandrel and inspected for anomalies.No ptfe coating peeling or any other anomalies were observed confirming that the ptfe coating remained firmly adhered to the guidewire.Based on the device inspection, the ptfe coating was confirmed to be scraped off as well as compressed at several places on the proximal section.The device directions for use (dfu) cautions the user to "securely fasten the torque device onto the wire to prevent slippage of the torque device and to avoid product damage (i.E., core wire abrasion/peeling of ptfe, etc.)".Therefore, it is possible that this damage may have been potentially caused by insecure tightening of the torque device collet.However, since the torque device was not returned for investigation, a definitive assessment could not be made.Therefore, a cause of 'undeterminable' has been assigned to the ptfe coating peeling issue.

Event Description

It was reported that prior to procedure, the polytetrafluoroethylene (ptfe) coating at the proximal portion of the guidewire (subject device) was flacking off.There was no patient involvement.

• Brand Name: SYNCHRO .014GUIDE WIRE 35 CM TIP
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT
• MDR Report Key: 7852951
• MDR Text Key: 119490606
• Report Number: 3012931345-2018-00005
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: 07613252186922
• Combination Product (y/n): N
• PMA/PMN Number: K032146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Catalogue Number: M00313010
• Device Lot Number: 0000006130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Initial Date Manufacturer Received: 08/12/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1