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

Catalog Number	SSFT215PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the operator advanced the subject guidewire with the microcatheter towards the intracerebral occlusion.However, the subject guidewire looped back.Next, the operator brought the microcatheter to obtain more support and pulled the guidewire back but the tip of the subject guidewire has broken off and remained in the vessel.The subject guidewire was removed and the operator proceeded to remove the clots.Next, the operator used the stent retriever to remove the broken tip.There was a surgical delay of unknown length due to this event.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated d4 expiration date - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire was noted to be fractured approximately 10cm from the distal tip.The guidewire nitinol tubing was noted to be broken 9cm from the distal tip.The guidewire distal tip was noted to be kinked/bent (shaped).The core wire distal end was observed through the distal tip dome.Functional inspection was not performed due to subject guidewire damage.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.It was reported that "i advanced the guidewire with a microcatheter and then the guidewire looped back.I was on my way to an intracerebral occlusion.Micro brought up to get more support.Next, i wanted to pull the guidewire back so that the tip pointed up again.However, i noticed that a piece of tip remained in the vessel.Then the guidewire was removed, but the tip remained in the vessel.First removed the clots and then removed the tip of the guide wire with the stent retriever." additional information provided by the customer indicated that "at the end of the procedure i noticed some resistance.When i checked the wire and try to move the wire i noticed that the wire tip was loose".The guidewire was returned and it was confirmed that the guidewire was fractured and the distal 10cm section had separated, there was some additional fracturing noted to the nitinol tubing near the initial fracture/separation point.The distal tip of the guidewire was noted to be bent/shaped.The damage to the distal tip, bending/shaping, is indicative of excessive forces on the guidewire, it was noted that the physician did not shape the wire.It is probable that there may have been procedural and/or anatomical factors present during the clinical procedure, causing excessive force to the distal end of the guidewire causing it to fracture during manipulation of the guidewire in the distal vasculature.An assignable cause of procedural factors will be assigned to the reported and analyzed event: guidewire distal tip broken/fractured during use and to the analyzed event: guidewire distal end/tip kinked/bent, 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 the procedure the operator advanced the subject guidewire with the microcatheter towards the intracerebral occlusion.However, the subject guidewire looped back.Next, the operator brought the microcatheter to obtain more support and pulled the guidewire back but the tip of the subject guidewire has broken off and remained in the vessel.The subject guidewire was removed and the operator proceeded to remove the clots.Next, the operator used the stent retriever to remove the broken tip.There was a surgical delay of unknown length due to this event.The procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: SYNCHRO SELECT-14 SOFT PS 215CM
• Common Device Name: 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: 19068556
• Report Number: 3012931345-2024-00058
• Device Sequence Number: 4732519
• Product Code: MOF
• UDI-Device Identifier: 07613327508598
• UDI-Public: 07613327508598
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 08/22/2026
• Device Catalogue Number: SSFT215PRE
• Device Lot Number: 0000551872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 06/09/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• 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: PROWLER PLUS CATHETER (NON-STRYKER); STENT RETRIEVER (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown