MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SOFT ST 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number SSFT215STR

Device Problem Peeled/Delaminated (1454)

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

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The device was returned and the lot number was not confirmed as no packaging was returned with the device.During visual inspection, the guidewire ptfe coating was noted to be peeling from 44cm from the proximal end in numerous areas.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.Hydrophilic coating was hydrated there were no anomalies noted.During the functional inspection the guidewire was advanced through the flushed microcatheter.The guidewire advanced through the catheter with no issues.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 not confirmed based on the device analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomaly noted to the device.It was reported that when the subject guidewire was inserted into the subject microcatheter at the preparation, there was considerable resistance in the middle part (shaft) of the microcatheter.Additional information provided by the customer indicated that flush was given inside the catheter at the time when the guidewire was inserted, the guidewire was not shaped, no friction or resistance was felt at the hub and the introducer sheath was used, when inserting the guidewire.Analysis of the returned device found that the ptfe coating was peeled, 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.The guidewire was advanced through the returned microcatheter without difficulty.An assignable cause of not confirmed will be assigned to the reported event of the guidewire difficult to advance, as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.An assignable cause of handling damage will be assigned to the analyzed damage of the guidewire ptfe coating peeling, 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.

Event Description

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

• Brand Name: SYNCHRO SELECT-14 SOFT 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: 17501840
• MDR Text Key: 321071244
• Report Number: 3012931345-2023-00185
• Device Sequence Number: 1
• Product Code: MOF
• UDI-Device Identifier: 07613327508574
• UDI-Public: 07613327508574
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SSFT215STR
• Device Lot Number: 0000183398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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
• Treatment: SL-10 CATHETER (STRYKER)