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

Model Number	SSTD215PRE
Medical Device Problem Codes	Fracture (1260); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, it was seen that an attempt had been made to shape the guidewire tip.The guidewire was noted to be kinked/bent at 100cm and 127cm from the proximal end.The guidewire ptfe coating was noted to be peeling in multiple areas to 40cm from the proximal end.The guidewire was noted to be broken/fractured at 209cm from the proximal end.The core wire distal end was observed through the distal tip.The hydrophilic coating was hydrated and there were no anomalies noted.A functional inspection could not be confirmed as the device was damaged.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 'guidewire difficult to advance' could not be confirmed; 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.It was reported that when the guidewire was inserted into a microcatheter, resistance was observed about 20cm from the microcatheter tip.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, excessive force was not applied while advancing the guidewire inside the microcatheter, and there was no allegation against the microcatheter.The inner diameter and model of the microcatheter used in the procedure were unknown.The following defects were noted during analysis of the returned device: the guidewire was kinked/bent at 100cm and 127cm from the proximal end.The guidewire ptfe coating was noted to be peeling in multiple areas up to 40cm from the proximal end.The guidewire was noted to be broken/fractured at 209cm from the proximal end.The ptfe coating damage most likely occurred as a result of interaction with another 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 as analyzed 'guidewire ptfe coating peeling' since this issue 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.It is probable that the guidewire encountered some procedural and/or anatomical factors during use that caused the reported resistance in the microcatheter.As a result, it is likely that the guidewire was damaged when it was manipulated against this resistance.An assignable cause of procedural factors will be assigned to the as reported ¿guidewire difficult to advance' and the as analyzed 'guidewire kinked/bent' and '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.
Event or Problem Description
Analysis of the returned device found that the ptfe coating of the guidewire (subject device) was peeled off.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

• Brand Name: SYNCHRO SELECT-14 STANDARD PS 215CM
• Common Device Name: 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: 15650458
• Report Number: 3012931345-2022-00191
• Device Sequence Number: 11395554
• Product Code: MOF
• UDI-Device Identifier: 07613327508512
• UDI-Public: 07613327508512
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2024
• Device Model Number: SSTD215PRE
• Device Catalogue Number: SSTD215PRE
• Device Lot Number: 0000081922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown