MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-35CM; WIRE, GUIDE, CATHETER

Model Number M00313310

Device Problem Fracture (1260)

Patient Problems Stroke/CVA (1770); Paralysis (1997); Vasoconstriction (2126); Foreign Body In Patient (2687)

Event Date 10/12/2022

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during a neurovascular procedure the operator placed the subject guidewire that was shaped at 45 degrees to the target lesion and then advanced a balloon to pre-dilate the the lesion.The operator then exchanged the balloon with the microcatheter, during this exchange the subject guidewire migrated back and the operator re-delivered it to the target lesion.The operator then guided the microcatheter over the subject guidewire to the target lesion.When the operator attempted to withdraw the subject guidewire, the subject guidewire stuck at the right pca (posterior communicating artery) p1 and could not be removed.The operator noted spasm in the target vessel which was simulated by the subject guidewire and therefore injected medicine (nimotop) to relieve the spasm.The operator then exchanged the microcatheter with another microcatheter and balloon to try to remove the subject guidewire but all failed.Therefore the operator decided to finish the procedure on that day by leaving the subject guidewire in patient's vessel until the next day.A second surgery was performed next day to remove the subject guidewire.However, the subject guidewire was still not able to be removed.During this second surgery, the tip (about 20cm) of the subject guidewire was fractured and left inside the patient's vessel and the procedure was completed.Post procedure the patient suffered hemiplegia on the right side of the body due to left posterior cerebral artery occlusion.It is noted that the patient is put on papaverine medication.No further information is available.

Event Description

It was reported that during a neurovascular procedure the operator placed the subject guidewire that was shaped at 45 degrees to the target lesion and then advanced a balloon to pre-dilate the the lesion.The operator then exchanged the balloon with the microcatheter, during this exchange the subject guidewire migrated back and the operator re-delivered it to the target lesion.The operator then guided the microcatheter over the subject guidewire to the target lesion.When the operator attempted to withdraw the subject guidewire, the subject guidewire stuck at the right pca (posterior communicating artery) p1 and could not be removed.The operator noted spasm in the target vessel which was simulated by the subject guidewire and therefore injected medicine (nimotop) to relieve the spasm.The operator then exchanged the microcatheter with another microcatheter and balloon to try to remove the subject guidewire but all failed.Therefore the operator decided to finish the procedure on that day by leaving the subject guidewire in patient's vessel until the next day.A second surgery was performed next day to remove the subject guidewire.However, the subject guidewire was still not able to be removed.During this second surgery, the tip (about 20cm) of the subject guidewire was fractured and left inside the patient's vessel and the procedure was completed.Post procedure the patient suffered hemiplegia on the right side of the body due to left posterior cerebral artery occlusion.It is noted that the patient is put on papaverine medication.No further information is available.

Manufacturer Narrative

There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot 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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared for use as per the directions for use, the guidewire tip was shaped about 45 degrees, continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was moderately tortuous.The guidewire was within the microcatheter when the issue occurred.The microcatheter was able to be withdrawn.The microcatheter and balloon were not able to move over the guidewire to cover the distal pit completely.There was no friction/resistance encountered during the procedure.According to the physician the cause of the guidewire getting stuck in the vessel is unknown.According to the physician the cause of vasospasm was stimulus from the guidewire.The spasm was relieved by injecting nimotop.According to the physician the cause of the hemiplegia was left posterior cerebral artery occlusion.The patient was put on added medication, papaverine due to the reported event.There is no future procedure planned for the patient to remove the broken guidewire.The patient's current condition is stable.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 for the as reported ¿device difficulty engaging target vessel¿ and ¿guidewire distal tip broken/fractured during use¿.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient vasospasm serious¿ and ¿patient stroke¿ 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.

• Brand Name: SYNCHRO-14 STRAIGHT 300-35CM
• Type of Device: WIRE, GUIDE, CATHETER
• 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: 15765162
• MDR Text Key: 303390506
• Report Number: 3012931345-2022-00204
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00313310
• Device Catalogue Number: M00313310
• Device Lot Number: 0000135008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BALLOON (UNKNOWN); EXCELSIOR SL-10 (STRYKER); EXCELSIOR XT-27 (STRYKER); PTA BALLOON (UNKNOWN)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: Asian