MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313010
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the lot number was confirmed with the packaging returned with the device.During visual inspection, the guidewire distal tip was noted to be kinked/bent.The guidewire ptfe (polytetrafluoroethylene) coating was noted to be peeling in multiple areas to 44cm from the proximal end.The core wire distal end was observed through the distal tip dome.Hydrophilic coating was hydrated there were no anomalies noted.Functional testing was not completed due to device condition.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that unpacked a synchro guidewire and no anomaly was noticed.During flushing, the operator found the tip of guidewire was kinked.The device was returned and it was confirmed that the distal tip of the guidewire had been kinked and the proximal ptfe coating was noted to be peeled.It is possible that the guidewire was damaged during removal from its packaging hoop, therefore an assignable cause of handling damage will be assigned to the reported and analyzed event of guidewire distal end/tip kinked/bent.The peeling noted to the ptfe coating is indicative of interaction with an under tightened torque device or backloading through the introducer.An assignable cause of handling damage will be assigned to the reported and analyzed event of guidewire ptfe coating peeling.
Event or Problem Description
The guidewire (subject device) was returned for analysis and during device investigation, it was discovered that the guidewire (subject device) ptfe (polytetrafluoroethylene) inner coating was peeling from the body of the guidewire.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO-14 STRAIGHT 200-35CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 20611763
• Report Number: 3012931345-2024-00194
• Device Sequence Number: 8163990
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: (01)07613252186922(17)250124(10)0000219065
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002907
• 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
• Report Date (Section B): 11/05/2024

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: 01/24/2025
• Device Catalogue Number: M00313010
• Device Lot Number: 0000219065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian