MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-17 FLEX STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M003C1715ST0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the left middle carotid artery (mca) procedure, the operator delivered a subject microcatheter to the designated position and then delivered a stent through the subject microcatheter.When the stent was approximately 5cm from the tip of the subject microcatheter, the operator noticed that the marker at the stent's distal end had opened.Subsequently, the microcatheter and stent were withdrawn together.Upon withdrawal, it was found that the subject microcatheter had broken approximately 5cm from its tip, which was the location where the stent's distal end had opened.After observing that the patient's blood flow was maintained, the physician concluded the surgery.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the distal 3cm section of the catheter was noted to be broken/fractured.There was also some kinking noted to the distal section.There was stretching noted to the proximal side of the fracture.During functional test the catheter was unable to be flushed.A patency mandrel was unable to be advanced beyond 15cm from the proximal end.The device was soaked and cut at 20 cm, a patency mandrel advanced again dried blood exited the catheter shaft as per photo 6.Blood was flushed from the catheter as per photo 7.A patency mandrel was advanced again and as unable to advance beyond the stretched/deformed section of the catheter.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 was confirmed based on analysis of the returned product.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use and no damage was noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/prior to use on the patient.Also, continuous flush was set up and maintained throughout the clinical procedure.It was reported that when the stent was approximately 5cm from the tip of the subject microcatheter, the physician noticed that the marker at the stent's distal end had opened.Subsequently, the microcatheter and stent were withdrawn together.Upon withdrawal, it was found that the microcatheter had broken approximately 5cm from its tip, which was the location where the stent's distal end had opened.During analysis, the distal 3cm section of the catheter was noted to be broken/fractured.There was also some kinking noted to the distal section.There was stretching noted to the proximal side of the fracture.The catheter was unable to be flushed.A patency mandrel was unable to be advanced beyond 15cm from the proximal end.The device was soaked and cut at 20 cm, a patency mandrel advanced again dried blood exited the catheter shaft.Blood was flushed from the catheter.A patency mandrel was advanced again and as unable to advance beyond the stretched/deformed section of the catheter.Based on a review of all available information and the analysis of the returned device it is probable that there was an issue with flush during the procedure due to the volume of procedural fluid in the catheter shaft causing the difficulties delivering the stent.The microcatheter shaft may have been damaged when the resistance was encountered.An assignable cause of procedural factors will be assigned to the as reported and as analysed event: 'catheter shaft broken/fractured during use' as well as the as analysed events: 'catheter tip kinked/bent', ¿catheter shaft stretched', 'catheter shaft friction', 'device difficult to flush', 'catheter shaft blocked/occluded' 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.
Event or Problem Description
It was reported that during the left middle carotid artery (mca) procedure, the operator delivered a subject microcatheter to the designated position and then delivered a stent through the subject microcatheter.When the stent was approximately 5cm from the tip of the subject microcatheter, the operator noticed that the marker at the stent's distal end had opened.Subsequently, the microcatheter and stent were withdrawn together.Upon withdrawal, it was found that the subject microcatheter had broken approximately 5cm from its tip, which was the location where the stent's distal end had opened.After observing that the patient's blood flow was maintained, the physician concluded the surgery.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR XT-17 FLEX 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: 21850595
• Report Number: 3008881809-2025-00212
• Device Sequence Number: 7963494
• Product Code: DQY
• UDI-Device Identifier: 07613252714903
• UDI-Public: (01)07613252714903(17)260625(10)25015673
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142565
• 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): 07/02/2025

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 Expiration Date: 06/25/2026
• Device Catalogue Number: M003C1715ST0
• Device Lot Number: 25015673
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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: NEUROFORM ATLAS STENT (STRYKER).
• Patient Sex: Unknown
• Patient Race: Asian