MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO .014GUIDE WIRE 45 CM TIP; WIRE, GUIDE, CATHETER

Catalog Number	M00313020
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during preparation for the procedure, the polytetrafluoroethylene (ptfe) coating on the guidewire had peeled.The physician replaced it with a new guidewire and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The torque device used with the guidewire was not returned.Analysis of the returned device revealed that the ptfe (polytetrafluoroethylene) coating was peeled/scraped off on several places along its proximal section between 15.0cm to 28.0cm section (from its proximal end).The ptfe coating was scrapped 360 degrees on the wire and on several places along the guidewire proximal length.The ptfe coating appeared to be scraped off of the guidewire with the torque device collet.The hydrophilic coating and distal section was examined and bubbles with uncollapsed and collapsed domes and an unknown substance were found on several places along its distal approximately 9.0cm section.The hydrophilic coating was examined wet and the wet guidewire middle and distal tip nitinol section revealed slight uneven swelling of the hydrophilic coated section.No other anomalies were noted.Functional testing could not be performed due to the nature of the complaint.However, the ptfe coating was tested and there was proper adhesion of the coating on the guidewire.The ptfe coating appeared to be scraped off of the guidewire during use with the torque device; however, because the torque device was not returned with the guidewire, the cause of the ptfe peeling cannot be definitely determined.
Event or Problem Description
It was reported that during preparation for the procedure, the polytetrafluoroethylene (ptfe) coating on the guidewire had peeled.The physician replaced it with a new guidewire and continued the procedure without clinical consequences to the patient.

• Brand Name: SYNCHRO .014GUIDE WIRE 45 CM TIP
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 8299062
• Report Number: 3012931345-2019-00015
• Device Sequence Number: 19468031
• Product Code: DQX
• UDI-Device Identifier: 07613252186939
• UDI-Public: 07613252186939
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032146
• 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): 03/22/2019

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: 06/12/2020
• Device Catalogue Number: M00313020
• Device Lot Number: 0000009888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR