MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 STANDARD ST 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number SSTD215STR

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2023

Event Type  malfunction  

Event Description

The subject guidewire was returned for analysis and it was discovered that the guidewire (subject device) ptfe (polytetrafluoroethylene) coating was noted to be peeling.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection an attempt had been made to shape the guidewire tip.The guidewire was noted to be kinked/bent from 77cm to 167cm from the proximal end.The guidewire ptfe (polytetrafluoroethylene) coating was noted to be peeling in multiple areas to 40cm from the proximal end.The core wire distal end was observed through the distal tip dome.The guidewire was soaked in water.After soaking the guidewire, it was inspected wet.The hydrophilic coating was intact.The guidewire distal tip revealed slight uneven swelling/bulge on its distal tip.When dry after approximately 10 seconds, the distal tip showed no anomaly and the swelling/bulge had disappeared.During functional inspection the guidewire was advanced through a flushed demonstration microcatheter, slight friction was noted as the guidewire advanced towards the distal end of the microcatheter.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.Additional information provided by the customer indicated that continuous flush set up and maintained throughout the procedure.No damage was noted to the packaging prior to opening, the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu.During analysis, the guidewire ptfe coating was noted to be peeling in multiple areas to 40cm from the proximal end, the peeling most likely occurred as a result of interaction with another device.It is most likely the torque device was not securely fastened causing it to drag down the wire during use.The guidewire was noted to be kinked/bent from 77cm to 167cm from the proximal end.The guidewire distal tip revealed slight uneven swelling/bulge on its distal tip, when dry after approximately 10 seconds, the distal tip showed no anomaly and the swelling/bulge had disappeared.During the dimensional inspection, the outer diameters (od's) were confirmed to be within specification when the device was both wet and dry.During the functional inspection, the guidewire was advanced through a flushed demonstration microcatheter and slight friction was noted towards the distal end of the microcatheter.An assignable cause of undeterminable will be assigned to the reported and analysed defect "guidewire difficult to advance" and to the analysed defects 'guidewire friction" and "device has cosmetic/appearance issue", as a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.An assignable cause of handling damage will be assigned to the analysed defects 'guidewire ptfe coating peeling' and 'guidewire kinked/bent' as these issues are due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: SYNCHRO SELECT-14 STANDARD ST 215CM
• Type of Device: GUIDE, WIRE, CATHETER, NEUROVASCULATURE
• 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: 17546662
• MDR Text Key: 321691831
• Report Number: 3012931345-2023-00188
• Device Sequence Number: 1
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: 07613327508499
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SSTD215STR
• Device Lot Number: 0000210827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2022
• 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
• Treatment: SCEPTER XC BALLOON CATHETER (TERUMO).