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

Catalog Number	SSTD215PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject guidewire was used to gain access to a giant cavernous aneurysm in an attempt to treat with a flow diverting stent.Access proved to be extremely difficult, and the subject guidewire was used in conjunction with tenzing 5f microcatheter to try and get access through the outflow of the aneurysm.During this, the physician realized that the subject guidewire was not responding to the manipulation.The physicians thought the subject guidewire could have broken, due to the force that was exerted trying to get tenzing 5f microcatheter through the outflow.After pulling the system (tenzing and sofia 5f microcatheters) out, it was discovered that the distal portion of the subject guidewire broke off and the subject guidewire was able to be retrieved and nothing was left inside the patient.The procedure was completed with no complications due to the subject wire.The patient was unable to be treated due to the anatomy being so tortuous.
Event or Problem Description
It was reported that the subject guidewire was used to gain access to a giant cavernous aneurysm in an attempt to treat with a flow diverting stent.Access proved to be extremely difficult, and the subject guidewire was used in conjunction with tenzing 5f microcatheter to try and get access through the outflow of the aneurysm.During this, the physician realized that the subject guidewire was not responding to the manipulation.The physicians thought the subject guidewire could have broken, due to the force that was exerted trying to get tenzing 5f microcatheter through the outflow.After pulling the system (tenzing and sofia 5f microcatheters) out, it was discovered that the distal portion of the subject guidewire broke off and the subject guidewire was able to be retrieved and nothing was left inside the patient.The procedure was completed with no complications due to the subject wire.The patient was unable to be treated due to the anatomy being so tortuous.
Additional Manufacturer Narrative
D4 expiration date - added 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 inspection was performed as the distal 10cm section of the subject guidewire had been fractured.Functional test: the subject guidewire was hydrated and no anomalies wee noted to the coating.The fractured distal tip was hydrated and inserted into the hub/proximal end of a demonstration microcatheter without difficulty.Full functional testing could not be performed as the subject guidewire was broken/fractured.The reported complaint can be confirmed based on the analysis results.The device failed to meet specification when returned, based on the damage noted to the returned device.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 access proved to be extremely difficult, and this wire was used in conjunction with tenzing 5f to try and get access through the outflow of the aneurysm.During this, the physician realized that the wire was not responding to his manipulation.The physicians thought the subject guidewire could have been broken, due to the force that was exerted trying to get tenzing through the outflow.After pulling the system (tenzing and sofia 5f) out, it was discovered that the distal portion of the subject guidewire broke off.Thankfully, the subject guidewire was able to be retrieved and nothing was left inside the patient.Additional information provided states that the patient¿s anatomy was extremely tortuous and patient had a giant cavernous aneurysm.The device was returned and it was confirmed that the distal end of the subject guidewire had been fractured.As it was reported that access proved to be extremely difficult and force was exerted trying to get the tenzing through the outflow, this in conjunction with the extremely tortuous anatomy may have exerted excessive force on the subject guidewire in the attempts to manipulate the wire to its target, causing it to fracture in the process, an assignable cause of procedural factors will be assigned to the reported ¿¿guidewire distal tip broken/fractured during use¿ and ¿device difficulty engaging target vessel¿ and to the analysed ¿guidewire distal tip broken/fractured during use¿.

• Brand Name: SYNCHRO SELECT-14 STANDARD 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: 19392428
• Report Number: 3012931345-2024-00093
• Device Sequence Number: 7762478
• Product Code: MOF
• UDI-Device Identifier: 07613327508512
• UDI-Public: 07613327508512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 07/15/2024

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 Catalogue Number: SSTD215PRE
• Device Lot Number: 0000582328
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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: SL-10 MICROCATHETER (STRYKER); SOFIA 5F MICROCATHETER; TENZING 5F MICROCATHETER (UNKNOWN MANUFACTURER); XT-27 MICROCATHETER (STRYKER)
• Patient Sex: Unknown