MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 STANDARD STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Catalog Number M00326410

Device Problems Fracture (1260); Peeled/Delaminated (1454)

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

Event Date 06/09/2023

Event Type  malfunction  

Event Description

The device was returned for analysis and the investigation of the device revealed that the guidewire (subject device) ptfe coating was peeling and was broken/fractured during use.No clinical consequences were reported to the patient due to this event.

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 was returned in two fragments (199cm proximal fragment and 1cm distal fragment).The guidewire ptfe coating was seen to be peeling at roughly 132cm.The proximal fragment was inspected and the nitinol tubing was broken/fractured with the core wire exposed.The distal fragment was inspected and the nitinol tubing was broken/fractured with the core wire exposed.The core wire distal end was observed through the distal tip dome.Functional inspection was unable to perform due to damage of returned device.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 guidewire difficult to advance could not be confirmed/replicated due to the damaged device; however, the analysis results are consistent with the reported event.The reported guidewire distal tip stretched was confirmed during 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 the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the patient's anatomy was severely tortuous.During the visual inspection, the guidewire was noted to be returned broken/fractured in 2 fragments (199cm proximal fragment and 1cm distal fragment).The guidewire ptfe coating was seen to be peeling at roughly 132cm from the proximal end.On both the proximal and distal fragments, the nitinol tubing and core wire were noted to be broken/fractured with the core wire exposed on the proximal fragment.The fragments were connected by stretched platinum wire.Although the fracture was not reported, it is likely that the stretched platinum wire that resulted from the fracture was interpreted as a stretched wire in the event description.Therefore, the reported event was confirmed.Based on the analysis and information provided, it is probable that due to tortuous anatomy, the guidewire experienced high tension and/or torsion forces during manipulation back and forth that caused it to fracture at the distal end.The exposed platinum wire connecting the segments was then stretched when it was pulled back.An assignable cause of procedural factors will be assigned to the reported and analyzed damage of the guidewire distal tip stretched and to the reported event of the guidewire difficult to advance as well as the analyzed damage of the guidewire broken/fractured during use since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.The ptfe coating damage most likely occurred as a result of interaction with an accessory device.The damage noted is consistent with backloading the proximal end of the guidewire into the distal end of the introducer and pulling it through the introducer at an angle.An assignable cause of handling damage will be assigned to the analyzed damage of the guidewire ptfe coating peeling since this issue appears to be associated with 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: SYNCHRO2-14 STANDARD STRAIGHT 200CM
• Type of Device: 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: 17672520
• MDR Text Key: 322540346
• Report Number: 3012931345-2023-00202
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04546540688767
• UDI-Public: 04546540688767
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053268
• 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: 09/01/2023

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 Catalogue Number: M00326410
• Device Lot Number: 0000213147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Race: Asian