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

Catalog Number	M003XT2750910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 catheter shaft was broken/fractured directly below the hub.The catheter shaft was kinked 48cm from the proximal fractured shaft.The catheter shaft was flattened crushed in multiple areas 134cm - 148.4cm from the proximal fractured shaft.The catheter hub was intact.The catheter tip was flattened.During functional inspection the catheter could not be flushed due to the condition of the returned device.The 0.0265" patency mandrel could not be inserted through the proximal end; therefore, was inserted distally.There was friction felt when the patency mandrel met the flattened section.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 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.It was reported during an aneurysm flow-diverting stent surgery, that the physician used a microcatheter to deliver a flow diverter stent.When the stent was delivered to the middle segment of the microcatheter, the connection between the proximal end of the catheter and the hub broke.The physician then withdrew the system and used the flow-diverting stent introducing sheath to retrieve the stent.Afterwards, a new microcatheter was used to successfully deploy the stent.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.Also, additional information indicated the patient¿s anatomy was moderately tortuous and resistance was encountered in the middle of the catheter.The device was returned for analysis, and it was noted that the catheter shaft was broken/fractured just below the hub.The catheter shaft was kinked and flattened.The catheter tip was flattened.The 0.0265" patency mandrel could not be inserted through the proximal end; therefore, was inserted distally.There was friction felt when the patency mandrel met the flattened section.Based on a review of all available information and the analysis of the returned device it is probable that the catheter shaft was fractured when resistance was encountered advancing the stent.There may have been resistance due to some procedural factors during the procedure.The complaint was reported for hub broken/fracture; however, the location of the fracture on the catheter shaft would have been perceived as hub fracture.The as reported events: 'catheter hub broken/fractured' and 'catheter shaft friction' as well as the as analyzed events: 'catheter shaft broken/fractured during use', 'catheter shaft kinked/bent', 'catheter shaft flat/crushed' and '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 anatomical factors during use, the product performance was limited.
Event or Problem Description
The subject catheter was returned for analysis and was examined.During device investigation and analysis, it was discovered that the subject catheter shaft was broken/fractured directly below the hub.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR XT-27 STD PRE-SHAPED 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: 22325009
• Report Number: 3008881809-2025-00359
• Device Sequence Number: 8924088
• Product Code: DQY
• UDI-Device Identifier: 04546540698155
• UDI-Public: (01)04546540698155(17)270515(10)24951518
• 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
• Report Date (Section B): 06/24/2025

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 Catalogue Number: M003XT2750910
• Device Lot Number: 24951518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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: SURPASS EVOLVE STENT (STRYKER).
• Patient Sex: Unknown
• Patient Race: Asian