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	11/20/2024
Type of Reportable Event	Malfunction
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 a visual inspection, the catheter distal end was found to be kinked/bent.The catheter shaft was found to be flat/crushed.The catheter shaft was found to be broken/fractured.The hub and the tip were found to be intact.A functional inspection was not required.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 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 there was no damage 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, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure.The patients anatomy was severely tortuous.It was reported that the patient's vessel was tortuous and the resistance when deploying the flow diverter was quite big so when the operator deployed the stent, the connection between proximal hub and the catheter shaft was fractured.During analysis, the catheter distal end was found to be kinked/bent, the catheter shaft was found to be flat/crushed, and the catheter shaft was found to be broken/fractured under the strain relief, which could have been perceived by the physician to be the hub that was broken.It is probable that manipulation of the device due resistance, and the patients severely tortuous anatomy would have caused the damage noted during analysis.An assignable cause of procedural factors will be assigned to the as reported 'catheter hub broken/fractured' as well as the as analyzed 'catheter tip kinked/bent', 'catheter shaft flat/crushed' and 'catheter shaft broken/fractured during use' 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
The catheter (subject device) was returned for analysis and it was discovered that the catheter shaft (subject device) was broken/fractured during use.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: 21447178
• Report Number: 3008881809-2025-00100
• Device Sequence Number: 17972076
• Product Code: DQY
• UDI-Device Identifier: 04546540698155
• UDI-Public: (01)04546540698155(17)270407(10)24879777
• 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): 02/24/2025

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: 24879777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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: LATTICE FLOW DIVERTER (NON-STRYKER).
• Patient Sex: Unknown