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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the physician followed the standard procedure to place the subject catheter, and no resistance was encountered throughout the process.However, while reviewing the x-ray, they noticed an abnormal spot, which was later identified as the tip of the subject catheter appearing uneven (possibly cracked).The patient remained clinically stable.The procedure was completed successfully.No additional information is available.
Event or Problem Description
It was reported that during the procedure the physician followed the standard procedure to place the subject catheter, and no resistance was encountered throughout the process.However, while reviewing the x-ray, they noticed an abnormal spot, which was later identified as the tip of the subject catheter appearing uneven (possibly cracked).The patient remained clinically stable.The procedure was completed successfully.No additional information is available.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.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 seen to be flat/crushed and kinked/bent in numerous areas along the catheter shaft.The outer layer of the shaft at the tip was detached and the marker band was exposed.The marker band was seen to be attached.A functional inspection was not performed.The reported 'catheter tip broken/fractured during use' was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to 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.It was reported that while reviewing the x-ray, they noticed an abnormal spot, which was later identified as the tip of the catheter appearing uneven (possibly cracked).During analysis, the catheter shaft was seen to be flat/crushed and kinked/bent in numerous areas along the catheter shaft.The outer layer of the shaft at the tip was detached and the marker band was exposed.The marker band was seen to be attached.Based on a review of all available information and the analysis of the returned device it is probable that the catheter shaft was damaged during manipulation during navigation to the target vessel, the extent of the damage noted to the distal tip is indicative of excessive pull/push force exerted on the device during use.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'catheter tip broken/fractured during use' as well as the as analyzed 'catheter shaft kinked/bent' and 'catheter shaft flat/crushed' 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 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: 23791754
• Report Number: 3008881809-2025-00705
• Device Sequence Number: 10465190
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: (01)04546540698131(17)280421(10)25551668
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 02/18/2026

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: M003XT2750810
• Device Lot Number: 25551668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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
• Patient Sex: Female