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	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports (2nd mdr).
Event or Problem Description
It was reported that during the procedure, an elongated internal carotid artery with multiple hairpin bends made it difficult to reach the occlusion.The physician removed the subject microcatheter with the guidewire from the patient.The subject microcatheter and guidewire were broken.No additional information available.
Event or Problem Description
It was reported that during the procedure, an elongated internal carotid artery with multiple hairpin bends made it difficult to reach the occlusion.The physician removed the subject microcatheter with the guidewire from the patient.The subject microcatheter and guidewire were broken.No additional information available.
Additional Manufacturer Narrative
This is 2 of 2 reports (2nd mdr) section d4: lot#, expiration date and gtin: updated section d9: product returned to stryker and returned to manufacturer on: updated section e1: initial reporter name, initial reporter first name and initial reporter last name: updated section e2: health professional and health professional occupation: updated section g2: initial reporter type: updated section h3: device evaluated by mfg: updated section h4: manufacturing date: updated due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product meet specifications upon release.During visual inspection it was observed that the subject catheter was returned with the returned guidewire jammed due to damage.The catheter shaft was seen to be broken in numerous locations from 137.5cm from the catheter hub.The catheter shaft was noted to be flat/crushed in numerous areas from 132cm.The catheter tip was noted to be damaged.The catheter hub was intact.Functional inspection was not performed as defects confirmed during analysis.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.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 patient's anatomy was quite tortuous with a strongly elongated internal carotid with multiple hairpin bends, which made it difficult to reach the occlusion.The subject microcatheter with guidewire was removed from the patient, the microcatheter was in several pieces.During analysis, the subject catheter was returned with the returned guidewire jammed due to damage.The catheter shaft was seen to be broken in numerous locations from 137.5cm from the catheter hub.The catheter shaft was noted to be flat/crushed in numerous areas from 132cm, and the catheter tip was noted to be damaged.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 of the device during the attempt to advance to the target occlusion and was further damaged during the attempt to remove the devices from the patient.The extent of the damage noted to the returned devices is indicative of extreme force to the devices.An assignable cause of procedural factors will be assigned to the as reported/as analyzed events 'catheter shaft broken/fractured during use' and the as reported event 'device difficulty engaging target vessel' as well as the as analyzed event 'catheter jammed', 'catheter shaft flat/crushed', and 'catheter tip damage' as the issue is associated with a product that meets company¿s 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.

• 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: 22080109
• Report Number: 3008881809-2025-00297
• Device Sequence Number: 15586108
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: (01)04546540698131(17)270831(10)25149065
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/21/2025

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: M003XT2750810
• Device Lot Number: 25149065
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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: SYNCHRO GUIDEWIRE (STRYKER).
• Patient Sex: Unknown