MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-35CM; WIRE, GUIDE, CATHETER

Catalog Number M00313310

Device Problem Peeled/Delaminated (1454)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

It was reported that during a neurovascular procedure the operator felt friction advancing the subject guidewire through the catheter.The subject guidewire was withdrawn and it was found to be kinked and the coating on the guidewire peeled off.The subject guidewire was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during a neurovascular procedure the operator felt friction advancing the subject guidewire through the catheter.The subject guidewire was withdrawn and it was found to be kinked and the coating on the guidewire peeled off.The subject guidewire was replaced and the procedure was completed successfully.No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 subject device was returned for analysis.The guidewire was noted to be kinked at 79cm from the proximal end of the guidewire.The guidewire nitinol tubing was noted to be broken/fractured at 87cm from the proximal end.The proximal and distal fragment was inspected, and the nitinol tubing was broken/fractured with the core wire and platinum wire still connected but stretched and broken.The guidewire ptfe (polytetrafluoroethylene) coating was seen to be peeling at 105cm and 121cm from the proximal end of the guidewire.The core wire distal end was observed through the distal tip dome.The guidewire distal tip was hydrating, no anomalies were noted.Functional inspection: guidewire difficult to advance functional test could not be performed due to damage (fracture).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 events can be 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 during delivery the operator felt friction.Withdrew the guidewire out and found the coating of it peeled off and kinked.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was severely tortuous.During analysis it was noted that the guidewire had been broken/fractured, stretched, the guidewire was kinked and there was peeling noted to the ptfe coating.It is probable that the guidewire experienced tension and/or torsion forces while navigating inside the anatomy of the patient, due to the tortuous anatomy of the patient resulting in the kinking, fracture and stretching noted to the guidewire.An assignable cause of procedural factors will be assigned to the reported guidewire difficult to advance and guidewire kinked/bent and to the analyzed guidewire kinked/bent, guidewire distal tip stretched and guidewire broken/ fractured during use, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.The peeling noted to the ptfe coating is indicative of interaction of the wire while backloading of the wire through the introducer.The as analyzed ¿guidewire ptfe coating peeling¿ will be assigned handling damage as the issue is 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-14 STRAIGHT 300-35CM
• 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: 17631427
• MDR Text Key: 322049722
• Report Number: 3012931345-2023-00199
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: 07613252186946
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2024
• Device Catalogue Number: M00313310
• Device Lot Number: 0000102461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: Asian