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 09/07/2023

Event Type  malfunction  

Event Description

Analysis of the returned device found that the subject guidewire polytetrafluoroethylene (ptfe) coating was peeled.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

Manufacturer Narrative

There are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the guidewire was noted to be kinked at 131cm.The guidewire ptfe was peeling at 24cm.The core wire distal end was observed through the distal tip dome.The guidewire distal tip revealed slight uneven swelling/bulge on its distal tip after hydrating.When dry after approximately 10 seconds, the distal tip showed no anomaly and the swelling/bulge had disappeared.During functional inspection, the guidewire was soaked in warm water for approximately 2 minutes, the demo microcatheter was flushed and the guidewire was advanced with slight friction felt throughout.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 there was no damage noted to the packaging prior to opening the packaging, there was no anomalies noted to the device during initial inspection and preparation, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure.As a root cause for the analyzed defect has not yet been identified an assignable cause of undeterminable will be assigned to the analyzed defect device has cosmetic/appearance issue and the analyzed and reported guidewire difficult to advance.An assignable cause of 'handling damage' will be assigned to the as analyzed guidewire kinked/bent and guidewire ptfe coating peeling as the defect appears to be associated with handling of the product or portion of the product during preparation.

• 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: 18148635
• MDR Text Key: 328282986
• Report Number: 3012931345-2023-00247
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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: 0000301190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• 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
• Treatment: PHENOM MICROCATHETER (MEDTRONIC)