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

Catalog Number M00313010

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

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.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 (189.9cm proximal fragment and 9.5cm distal fragment).The guidewire was noted to be kinked bent at 60cm and 85.6cm.The guidewire ptfe coating was seen to be peeling in multiple areas from roughly 26.5cm.The proximal fragment was inspected, and the nitinol tubing was broken/fractured with the core wire exposed and broken.The distal fragment was inspected, and the nitinol tubing was seen to be broken/fractured with the core wire exposed and broken.The core wire distal end was observed through the distal tip dome.Functional inspection was unable to perform due to damage.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 event of guidewire kinked/bent was confirmed based on the analysis of the returned device.The reported event of the 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 device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During visual inspection, the guidewire was noted to be kinked/bent at 60cm and 85.6cm from the proximal end and the guidewire was returned broken in 2 fragments (189.9cm proximal fragment and 9.5cm distal fragment).The nitinol tubing was broken/fractured with the core wire exposed and broken on both the proximal and distal fragments.The ptfe coating was noted to be peeling in multiple areas from roughly 26.5cm from the proximal end.Functional testing was unable to be performed due to the damage noted.Based on the analysis, it is probable that the guidewire experienced high tension and/or torsion forces while navigating inside the microcatheter to the aneurysm, and this caused the wire to kink and fracture.An assignable cause of procedural factors will be assigned to the reported and analyzed damage of the guidewire kinked/bent, the as reported event of the guidewire difficult to advance and the as analyzed damage of the guidewire distal tip 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 another device.The damage noted is consistent with insecure fastening of the torque device on the wire which can result in slippage and can cause abrasion/peeling of the ptfe layer.An assignable cause of handling damage will be assigned to the as analyzed damage of the guidewire ptfe coating peeling since this defect is 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: SYNCHRO-14 STRAIGHT 200-35CM
• 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: 17761021
• MDR Text Key: 323744097
• Report Number: 3012931345-2023-00209
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: 07613252186922
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K032146
• 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: 09/15/2023

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: M00313010
• Device Lot Number: 0000209224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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