MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT STRAIGHT 215CM; WIRE, GUIDE, CATHETER

Catalog Number	S2SPS14215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the guidewire (subject device) distal tip was broken/fractured during use.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The device was returned with no packaging.During visual inspection the distal 5cm section of the guidewire had been fractured (nitinol tubing and core wire) and was still attached to the proximal section by the stretched platinum coil.Functional inspection not possible due to fracture.The reported guidewire distal tip stretched was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.Additional information provided by the customer indicated that there were no anomalies noted to the device during initial inspection and preparation, the device was prepared as per the dfu, the guidewire tip was shaped, the device navigated through a non tortuous ica, and there were no other difficulties encountered during usage of the device that could have contributed to the issue.During the visual inspection, it was noted that the distal 5cm section of the guidewire had been fractured (nitinol tubing and core wire) and was still attached to the proximal section by the stretched platinum coil.Therefore, the reported stretch was confirmed based on analysis.Based on the analysis, it is possible that the guidewire may have prolapsed at the distal tip during navigation and experienced high tension and/or torsion forces that caused it to fracture.The exposed platinum wire connecting the segments was likely stretched when pulling the wire back.An assignable cause of procedural factors will be assigned to the reported and analyzed damage of the guidewire distal tip stretched and to the analyzed damage of the 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.
Additional Manufacturer Narrative
We have addressed the fda request, received via email on 14 june 2024: upon review, we have determined that the device identification information about the suspect medical devices conflicts with the data submitted to the global unique device identification database (gudid).Discrepancies were noted in the information included for some or all of the device identification fields of the electronic equivalent of the fda form 3500a compared to the information included for the corresponding fields in the gudid.Additionally, the ¿unique device identifier (udi) #¿ field on the fda form 3500a should contain the entire udi number including the di and pi fields, all numbers, letters, parentheses, and symbols.Please verify that you have included the entire udi in the ¿unique device identifier (udi) #¿ field on the 3500a.We have reviewed the device identifier (di) and confirm that it is accurate and in alignment with the hl7 specifications released in 2017.Additionally, the 510(k) number has been corrected from from k053268 to k190843 in accordance with the global unique device identification database (gudid).
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the guidewire (subject device) distal tip was broken/fractured during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO2-14 SUPPORT STRAIGHT 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: 17858568
• Report Number: 3012931345-2023-00217
• Device Sequence Number: 5692574
• Product Code: DQX
• UDI-Device Identifier: 07613327459630
• UDI-Public: 07613327459630
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K190843
• 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,Followup
• Report Date (Section B): 08/14/2024

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: 06/06/2025
• Device Catalogue Number: S2SPS14215
• Device Lot Number: 0000141394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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
• Patient Sex: Unknown