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	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during middle cerebral artery (mca) stenosis procedure, the operator used the subject guidewire to deliver the microcatheter.However, after super selecting the operator felt the subject guidewire fractured so he took it out and confirmed it was fractured.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire was returned with only the proximal section present and broken in two locations.The proximal fragment was inspected, and the nitinol tubing was broken/fractured with the core wire exposed and broken.The second fracture was inspected and the nitinol tubing was seen to be broken/fractured with the platinum wire severely stretched.The distal fragment was not returned.Functional inspection was not performed as the guidewire was broken/fractured.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 device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure.The guidewire was returned with only the proximal section.It was noted to be broken/fractured across the nitinol tubing with the core wire exposed and platinum wire stretched.An assignable cause of procedural factors will be assigned to the reported event ¿guidewire broken/fractured during use¿ and analysed event ¿guidewire distal tip stretched¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during middle cerebral artery (mca) stenosis procedure, the operator used the subject guidewire to deliver the microcatheter.However, after super selecting the operator felt the subject guidewire fractured so he took it out and confirmed it was fractured.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during middle cerebral artery (mca) stenosis procedure, the operator used the subject guidewire to deliver the microcatheter.However, after super selecting the operator felt the subject guidewire fractured so he took it out and confirmed it was fractured.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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 k053268 to k190843 in accordance with the global unique device identification database (gudid).

• 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: 18070422
• Report Number: 3012931345-2023-00237
• Device Sequence Number: 7684754
• Product Code: DQX
• UDI-Device Identifier: 07613327459630
• UDI-Public: 07613327459630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 08/14/2024
• Initial Report FDA Received Date: 11/04/2023
• Supplement Report FDA Received Date: 12/13/2023; 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown
• Patient Race: Asian