MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M003XT2750810
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Foreign Body In Patient (2687)
Date of Event	03/08/2024
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 mca (middle cerebral artery) stenosis case, the operator used balloon to dilate first and then prepared to deploy stent to expand the lesion.Delivered the stent along with the guidewire to go through the subject catheter, and after the subject catheter was advanced in patient's body for about 140cm resistance was encountered and the operator could not see the tip marker of the subject catheter under dsa (digital subtraction angiography) even after several adjustments.After the procedure the operator checked the subject catheter and found the tip marker ring was missing.Checked with ct (computed tomography) and found metal matter in patient's head and it supposed to be the marker of the subject catheter.Additional information received on 12-mar-2024 stated that medical intervention was performed to remove catheter tip marker and patient's muscle tone increased.The procedure was completed successfully.No addiotnal information available.
Event or Problem Description
It was reported that during mca (middle cerebral artery) stenosis case, the operator used balloon to dilate first and then prepared to deploy stent to expand the lesion.Delivered the stent along with the guidewire to go through the subject catheter, and after the subject catheter was advanced in patient's body for about 140cm resistance was encountered and the operator could not see the tip marker of the subject catheter under dsa (digital subtraction angiography) even after several adjustments.After the procedure the operator checked the subject catheter and found the tip marker ring was missing.Checked with ct (computed tomography) and found metal matter in patient's head and it supposed to be the marker of the subject catheter.Additional information received on (b)(6) 2024 stated that medical intervention was performed to remove catheter tip marker and patient's muscle tone increased.The procedure was completed successfully.No addiotnal information available.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter shaft was found to be kinked/bent in multiply areas, the catheter shaft was found to be broken/fractured in multiply areas, the tip of the catheter was found to be broken off at 6 cm from the distal junction and not returned, and the hub was found to be intact.A functional inspection was unable to be performed due to condition of the device.The reported event is covered in the device direction 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 ro marker(s) detached/separated/not visible under fluoroscopy was confirmed during the analysis.The reported catheter shaft friction, un-retrieved device fragments, could not be duplicated during the analysis; however, analysis results are consistent with the reported event.The reported patient neurological deficit could not be duplicated during the analysis as the event is patient/procedure related.The reported defect was confirmed based on analysis of the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use and there was no damage noted to the packaging prior to opening the packaging.The customer indicated that the device was in good condition prior to use and continuous flush was set up and maintained throughout the clinical procedure.During one mca (middle cerebral artery) stenosis case, the operator used balloon to dilate first and then prepared to deploy a stent to expand the lesion.Delivered the stent along with the guidewire to go through the subject catheter, and after the microcatheter was advanced in patient's body for about 140cm, the operator could not see the tip marker of it under dsa (digital subtraction angiography) even after several adjustments.Since the microcatheter could not be seen, the operator then replaced it with another catheter to place and deployed the stent to finish the procedure successfully.After the procedure the operator checked the microcatheter and found the tip marker ring was missing.Checked with ct (computed tomography) and found metal matter in patient's head and it supposed to be the marker of the subject catheter.Also additional information provided indicated the patients anatomy was severely tortuous, they experienced difficulty advancing and still kept advancing the catheter.As per the catheter dfu (device directions for use) "never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the microcatheter or guidewire against resistance could dislodge a clot, perforate a vessel wall, or damage microcatheter and guidewire.In severe cases, tip separation of the microcatheter or guidewire may occur".The catheter shaft was returned severely damaged.The catheter shaft had fractured and the ro marker was detached.There was difficulty advancing the catheter during the procedure, the operator experienced difficulty advancing the catheter and kept advancing.The as reported 'ro marker(s) detached/separated/not visible under fluoroscopy', 'un-retrieved device fragments', and 'patient neurological deficit' as well as the as analyzed 'ro marker(s) detached/separated/not visible under fluoroscopy', 'catheter shaft kinked/bent', 'catheter shaft broken/fractured during use' will be assigned user error as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.There was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.The device was used in an mca (middle cerebral artery) stenosis case and the patients anatomy was severely torturous.The as reported 'catheter shaft friction' will be assigned procedural factors 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.

• Brand Name: EXCELSIOR XT-27 STD STRAIGHT 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18981341
• Report Number: 3008881809-2024-00123
• Device Sequence Number: 6213514
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: 04546540698131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113778
• 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): 06/12/2024

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: 07/31/2026
• Device Catalogue Number: M003XT2750810
• Device Lot Number: 24457064
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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: BALLOON (UNKNOWN).; EZ STENT (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Race: Asian