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

Catalog Number	SSUP215PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2024
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 right m1 middle cerebral artery acute ischemic stroke treatment procedure, the physician used the subject guidewire to access an artery in the patient neuroanatomy.The subject guidewire then appeared to be stuck at a right angle under fluoroscopic and then the tip of the subject guidewire was broken and was left inside the patient vessel.Physician attempted to remove the broken tip of the subject guidewire using micro snare but failed to do so.Heparin was given to the patient.The patient died on (b)(6) 2024, however, the physician stated that the death is not related to the subject guidewire and is caused due to the patient condition for presentation to hospital with acute ischemic stroke (ais) relating to intracranial atherosclerosis disease (icad).The patient autopsy was done on (b)(6) 2024.No additional information available.
Event or Problem Description
It was reported that during right m1 middle cerebral artery acute ischemic stroke treatment procedure, the physician used the subject guidewire to access an artery in the patient neuroanatomy.The subject guidewire then appeared to be stuck at a right angle under fluoroscopic and then the tip of the subject guidewire was broken and was left inside the patient vessel.Physician attempted to remove the broken tip of the subject guidewire using micro snare but failed to do so.Heparin was given to the patient.The patient died on (b)(6) 2024, however, the physician stated that the death is not related to the subject guidewire and is caused due to the patient condition for presentation to hospital with acute ischemic stroke (ais) relating to intracranial atherosclerosis disease (icad).The patient autopsy was done on (b)(6) 2024.No additional information available.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the distal 5.5cm was broken/fractured.The distal side of the fracture point was imaged with fracture to the nitinol tubing and fracture and bending noted to the core wire.The proximal side of the fracture point was imaged noting fracture to the nitinol tubing.The distal tip was hydrated and no abnormal anomalies were noted.Functional test was unable to perform as the distal tip had been 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 event was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomaly noted to the device.It was reported that the wire then appeared (under fluoroscopic imaging) to get 'stuck' at a right angle and then a small part of the wire snapped off (the tip) and was left inside the vessel.Considerable time was then spent attempting to retrieve the wire however this was not successful.Additional information provided by the customer indicated that the patient¿s anatomy was very tortuous.The guidewire was returned with the distal 5.5cm section of the wire broke/fractured, the distal section of the fracture had kinking and severe bending noted to the core wire.Based on review of all information and results of the device analysis, it is probable that the guidewire was subject to excessive forced during use causing the guidewire to fracture at the distal tip, this is evident from the damage noted to the fracture point.An assignable cause of procedural factors will be assigned to the as reported ¿guidewire distal tip broken/fractured during use¿, ¿guidewire difficult to advance¿ and ¿un-retrieved device fragments¿, and to the as analyzed ¿guidewire distal tip broken/fractured during use¿ and ¿guidewire distal end/tip kinked/bent¿, as this issue is 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.

• Brand Name: SYNCHRO SELECT-14 SUPPORT 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: 18597036
• Report Number: 3012931345-2024-00020
• Device Sequence Number: 20862282
• Product Code: MOF
• UDI-Device Identifier: 07613327508635
• UDI-Public: 07613327508635
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 03/20/2024

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: 05/04/2024
• Device Catalogue Number: SSUP215PRE
• Device Lot Number: 0000063484
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER (UNKNOWN).; MICRO SNARE (UNKNOWN).; RESOLUTE ONYX CORONARY STENT (MEDTRONIC).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG