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 05/22/2023

Event Type  malfunction  

Event Description

The guidewire (subject device) was returned for analysis and it was discovered that the guidewire (subject device) ptfe (polytetrafluoroethylene) coating was noted to be peeling.No further information available.

Manufacturer Narrative

Although the device history record (dhr) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire was returned together with the microcatheter, and it was found to be stuck inside the microcatheter.The guidewire was found to be kinked/bent in multiple areas.The core wire distal end was observed through the distal tip dome.The guidewire polytetrafluoroethylene (ptfe) coating was noted to be peeling in multiple areas.Functional inspection was not performed due to the guidewire could not be removed from the microcatheter.An attempt was made to remove the guidewire from the microcatheter for further analysis.The microcatheter was flushed but the guidewire remained stuck inside the catheter and was unable to be removed due to the condition of both devices.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 the subject guidewire got stuck on the stent during the procedure.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use, preparation/set-up was performed as per the dfu, continuous flush was maintained for the duration of the procedure, the treatment site was located at the middle cerebral artery (mca) bifurcation, the wire got stuck on the stent while re-crossing for y stenting, and the physician attempted to remove the broken stent with a snare.An assignable cause of procedural factors will be assigned to the reported and analyzed defect 'device interaction with another device' as well as the analyzed defect 'guidewire kinked/bent' and 'guidewire jammed' 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 defect '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: 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: 17626891
• MDR Text Key: 321988938
• Report Number: 3012931345-2023-00197
• Device Sequence Number: 1
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: 07613327508499
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: ATLAS STENT (STRYKER); SL-10 MICROCATHETER (STRYKER)