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	04/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual and microscopic inspection, it was seen that the subject microcatheter was returned along with stent.The shaft of the subject microcatheter was found to be kinked/bent in multiply areas and was found to be broken/fractured at 147 cm.The hub was found to be intact.Functional testing revealed that the coating was hydrated and there were no anomalies noted to the outer coating of the subject 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 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 and continuous flush was set up and maintained throughout the clinical procedure.Also, additional information indicated that the patient¿s anatomy was severely torturous which may have contributed to the event.During analysis, the subject microcatheter was seen to be kinked in multiple areas and the catheter shaft was broken/fractured at 147 cm.The as reported codes device difficulty engaging target vessel and unexpected movement of device and as analysed codes catheter shaft broken/fractured during use, catheter shaft kinked/bent, 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.
Event or Problem Description
It was reported that during a m2 bifurcation aneurysm case, subject microcatheter was used to deploy a stent.While doing so, the operator checked under digital subtraction angiography (dsa) and found the subject microcatheter migrated downward the aneurysm and could not be delivered to the location anymore.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.The subject microcatheter was returned for analysis and the device investigation revealed that the shaft of the subject microcatheter was found to be broken/fractured during use.The procedure was completed successfully.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: 18474904
• Report Number: 3008881809-2024-00012
• Device Sequence Number: 17873436
• Product Code: DQY
• UDI-Device Identifier: 07613252714903
• UDI-Public: 07613252714903
• 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
• Report Date (Section B): 01/09/2024

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: 08/21/2024
• Device Catalogue Number: M003C1715ST0
• Device Lot Number: 23821098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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: AXIUM COIL (MEDTRONIC); ECHELON-10 MICROCATHETER (MEDTRONIC); NEUROFORM ATLAS STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Race: Asian