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

Catalog Number	SSUP215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Vasoconstriction (2126); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of 2 reports.
Event or Problem Description
It was reported that during internal carotid artery (ica) thrombectomy, the subject guidewire device was used with other devices (vecta catheter, infinity catheter) in the vessel and tortuous aortic arch as the resistance was encountered when inserting the catheter device.Therefore, the subject guidewire device was withdrawn, as the tip of the subject guidewire snapped off.The snare was used to retrieve the fractured fragment part and completed the procedure.No other information was provided.
Additional Manufacturer Narrative
D4 expiration date added.D4 gtin corrected.D9 product available to stryker/ returned to manufacturer on updated.H3 device evaluated by mfg updated.H4 manufacturing date added.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection revealed that the distal end of the subject guidewire was noted to be broken along the nitinol tubing and the core and platinum wire approx.209cm from the proximal end.The subject guidewire was noted to be kinked/bent.The core wire distal end was observed through the distal tip dome.A functional inspection could not be performed due to the damage to the subject guidewire device.The reported ¿guidewire distal tip broken/fractured during use¿ was confirmed during analysis.The reported ¿patient vasospasm non serious¿ was unable to be confirmed as this is patient related.The device failed to meet specifications when received for complaint investigation, based on the damage noted.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.It was reported that there was spasm in the vessel and tortuous aortic arch.Resistance felt when inserting the axs vecta catheter device.He pulled back and then the outer part of axs vecta catheter device peeled off and snapped off.Also the tip of the subject guidewire was snapped off.Parts were snared away.In the distal part of vecta catheter device you can see a narrowing.Additional information provided by the customer states that no force was used to overcome resistance, the subject guidewire was torqued several times, there was not excessive force during torqueing the subject guidewire and the patients anatomy was very tortuous.In the physician¿s opinion, the kinking to the axs vecta catheter device was the cause of the fractured subject guidewire.The subject guidewire device was returned, and it was confirmed that the distal section of the subject guidewire had been fractured with notable kinking noted to the location of the fracture.The returned axs vecta catheter was noted to be extensively damaged to the distal end.The risk of vasospasm is indicated as an anticipated adverse event in the synchro ifu.It is probable that the vasospasm occurred due to advancement and manipulation of the devices through the patients anatomy, it is probable that the axs vecta catheter device was then damaged and the subject guidewire was further damaged during attempts to advance through the acs vecta catheter device.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient vasospasm non-serious¿, as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.An assignable cause of procedural factors will be assigned to the reported and analyzed ¿guidewire distal tip broken/fractured during use¿ and to the analyzed guidewire 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 internal carotid artery (ica) thrombectomy, the subject guidewire device was used with other devices (vecta catheter, infinity catheter) in the vessel and tortuous aortic arch as the resistance was encountered when inserting the catheter device.Therefore, the subject guidewire device was withdrawn, as the tip of the subject guidewire snapped off.The snare was used to retrieve the fractured fragment part and completed the procedure.No other information was provided.

• Brand Name: SYNCHRO SELECT-14 SUPPORT ST 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: 19818734
• Report Number: 3012931345-2024-00138
• Device Sequence Number: 15627020
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: (01)07613327508611(17)261010(10)0000569939
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 10/15/2024

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 Catalogue Number: SSUP215STR
• Device Lot Number: 0000569939
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: INFINITY CATHETER (STRYKER).; SNARE DEVICE.; VECTA CATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown