MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO .014GUIDE WIRE 300 CM LENGTH; WIRE, GUIDE, CATHETER

Catalog Number M00313310

Device Problem Flaked (1246)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2018

Event Type  malfunction  

Event Description

It was reported that during preparation, the coating of the guidewire was leaving flakes on the sterile table.No patient involvement was reported.

Event Description

It was reported that during preparation, the coating of the guidewire was leaving flakes on the sterile table.No patient involvement was reported.

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The returned synchro guidewire was examined under magnification and it was observed that the polytetrafluoroethylene (ptfe) coating was peeled/scrapped off on 130.0 cm section from proximal end and was compressed on several places on the proximal section.A swelling was also observed on the middle section of the nitinol hydrophilic coating after it was hydrated by soaking in water.Additionally, the section of the guidewire where the ptfe coating did not show any peeling was tested to ensure acceptable adhesion by wrapping around wrapping 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.No other anomalies were observed.Based on the additional information provided by the customer, no damage was noted to the packaging, the dispenser hoop was flushed with saline before removing the guidewire and no resistance was encountered when removing the guidewire from the dispenser hoop.The reported complaint that the guidewire ptfe coating peeled off was confirmed during visual inspection.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.At this time, the cause of the swelling observed on the hydrophilic coating cannot be definitely determined.Therefore, a cause of undeterminable has been assigned to the reported code 'nv - guidewire ptfe coating peeling¿ and all analyzed anomalies 'nv - guidewire ptfe coating peeling, nv - guidewire coating issue and nv - guidewire deformed'.

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The returned synchro guidewire was examined under magnification and it was observed that the polytetrafluoroethylene (ptfe) coating was peeled/scrapped off on 130.0 cm section from proximal end and was compressed on several places on the proximal section.A swelling was also observed on the middle section of the nitinol hydrophilic coating after it was hydrated by soaking in water.Additionally, the section of the guidewire where the ptfe coating did not show any peeling was tested to ensure acceptable adhesion by wrapping around wrapping 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.No other anomalies were observed.Based on the additional information provided by the customer, no damage was noted to the packaging, the dispenser hoop was flushed with saline before removing the guidewire and no resistance was encountered when removing the guidewire from the dispenser hoop.The reported complaint that the guidewire ptfe coating peeled off was confirmed during visual inspection.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.At this time, the cause of the swelling observed on the hydrophilic coating cannot be definitely determined.Therefore, a cause of undeterminable has been assigned to the reported code 'nv - guidewire ptfe coating peeling¿ and all analyzed anomalies 'nv - guidewire ptfe coating peeling, nv - guidewire coating issue and nv - guidewire deformed'.

Event Description

It was reported that during preparation, the coating of the guidewire was leaving flakes on the sterile table.No patient involvement was reported.

• Brand Name: SYNCHRO .014GUIDE WIRE 300 CM LENGTH
• 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: 7844771
• MDR Text Key: 119152785
• Report Number: 3012931345-2018-00004
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: 07613252186946
• 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: 01/02/2020
• Device Catalogue Number: M00313310
• Device Lot Number: 0000003134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1