MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO .010 WIRE SOFT STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Catalog Number M00316310

Device Problems Break (1069); Fracture (1260)

Patient Problems Thrombosis (2100); Thrombus (2101); Device Embedded In Tissue or Plaque (3165)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported during the procedure, the microcatheter tip fractured in the middle meningeal artery before reaching the target vessel.Shortly after, the guidewire (subject device) broke off in middle meningeal artery.The fragments of both the microcatheter and guidewire were not retrieved and remained inside the patient.In addition, the middle meningeal artery was thrombosed.Therefore, the physician abandoned the procedure.No further information was provided.

Manufacturer Narrative

The device history record for the reported synchro guidewire confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing 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.As per the event details a non-stryker catheter was being used which could have contributed to the failure, however it cannot be confirmed.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, a cause of undeterminable was assigned to the reported event of guidewire fracture and unretrieved fragments.The reported event of patient vessel thrombosis is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported during the procedure, the microcatheter tip fractured in the middle meningeal artery before reaching the target vessel.Shortly after, the guidewire (subject device) broke off in middle meningeal artery.The fragments of both the microcatheter and guidewire were not retrieved and remained inside the patient.In addition, the middle meningeal artery was thrombosed.Therefore, the physician abandoned the procedure.No further information was provided.

Manufacturer Narrative

D9/h3: product available to stryker ¿ updated d9: returned to manufacturer on ¿updated h3: device evaluated by mfg ¿updated during visual inspection, the guidewire was noted to be kinked at 12cm from the proximal end.The ptfe coating was also damaged at 18cm and 26cm from the proximal end.The distal end of the guidewire had been fractured with kinking core wire and the fractured section of the guidewire was not returned.A functional testing could not be performed due to the damage noted to the 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.In case of this complaint, the condition of the returned guidewire observed during product inspection suggests that excessive torque and manipulation during use resulted in the observed damage; therefore, an assignable cause of handing damage will be assigned to the reported issue guidewire broken/fractured during use and to the as analyzed issues guidewire kinked/bent and guidewire ptfe coating peeling.The other reported issues un-retrieved device fragments, and patient vessel thrombosis are known and anticipated complications to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported during the procedure, the microcatheter tip fractured in the middle meningeal artery before reaching the target vessel.Shortly after, the guidewire (subject device) broke off in middle meningeal artery.The fragments of both the microcatheter and guidewire were not retrieved and remained inside the patient.In addition, the middle meningeal artery was thrombosed.Therefore, the physician abandoned the procedure.No further information was provided.

• Brand Name: SYNCHRO .010 WIRE SOFT STRAIGHT 200CM
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 8998295
• MDR Text Key: 159125600
• Report Number: 3012931345-2019-00072
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K032146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Catalogue Number: M00316310
• Device Lot Number: 000019670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APOLLO MICROCATHETER(MEDTRONIC); MICROCATHETER (MEDTRONIC)
• Patient Outcome(s): Other
• Patient Age: 53 YR