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

Model Number	SSFT215PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure the tip of the guidewire (subject device ) broke.There had been some wire reshaping due to difficult anatomy.There was difficulty advancing the guidewire (subject device) but it went into the aneurysm for the most part.Also, there was some resistance when pulling the guidewire (subject device) out of the aneurysm.Possible that the guidewire (subject device) hooked a little in the stent.Then the distal part of the guidewire (subject device) was left in the microcatheter and this had to be pulled out to the intermediate catheter with the guidewire (subject device) and a medical intervention was performed as this had to secure it with a stent retriever when it seemed to drop.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.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that no anomalies were noted to the device during initial inspection and preparation, the device was prepared as per the dfu, a non-stryker microcatheter was used with the subject guidewire, the guidewire was reshaped due to difficult anatomy, continuous flush was maintained for the duration of the procedure, and friction/resistance was noted when the wire was attempted to be removed from the aneurysm.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that during the procedure the tip of the guidewire (subject device ) broke.There had been some wire reshaping due to difficult anatomy.There was difficulty advancing the guidewire (subject device) but it went into the aneurysm for the most part.Also, there was some resistance when pulling the guidewire (subject device) out of the aneurysm.Possible that the guidewire (subject device) hooked a little in the stent.Then the distal part of the guidewire (subject device) was left in the microcatheter and this had to be pulled out to the intermediate catheter with the guidewire (subject device) and a medical intervention was performed as this had to secure it with a stent retriever when it seemed to drop.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO SELECT-14 SOFT 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: 14069928
• Report Number: 3012931345-2022-00078
• Device Sequence Number: 2571702
• Product Code: MOF
• UDI-Device Identifier: 07613327508598
• UDI-Public: 07613327508598
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2024
• Device Model Number: SSFT215PRE
• Device Catalogue Number: SSFT215PRE
• Device Lot Number: 0000077797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown