MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-17 STD STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M003C1775ST0
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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/microscopic inspection, the catheter shaft was found to be kinked/bent.The catheter shaft was found to have a hole approximately 11cm from the hub.The catheter shaft was found to be flat/crushed.The hub and tip were intact.During functional inspection, the catheter shaft was flushed, a leak was identified where the hole is located 11cm from the hub.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.It was reported that when flushing the subject microcatheter after unpacked, the operator found the position at shaft about 10cm from hub was leaked with water.During analysis, the catheter shaft was found to be kinked/bent and flat/crushed.The catheter shaft was found to have a hole approximately 11cm from the hub.The catheter shaft was flushed, a leak was identified where the hole is located 11cm from the hub.It is probable that the damage noted to the device occurred when removing from the dispenser hoop or during preparation.An assignable cause of handling damage will be assigned to the as reported/as analyzed 'catheter shaft leak during preparation' and the as analyzed ''catheter shaft kinked bent', 'catheter shaft has hole/perforation' and 'catheter shaft flat/crushed' as these issues are due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
Analysis of the returned device revealed that subject catheter (subject device) shaft had a hole/perforation.There was no clinical consequence to the patient due to this event.

• Brand Name: EXCELSIOR XT-17 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: 21529702
• Report Number: 3008881809-2025-00118
• Device Sequence Number: 9584491
• Product Code: DQY
• UDI-Device Identifier: 07613252714866
• UDI-Public: (01)07613252714866(17)260526(10)24933186
• 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): 03/05/2025

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 Expiration Date: 05/26/2026
• Device Catalogue Number: M003C1775ST0
• Device Lot Number: 24933186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• 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: SYNCHRO2 GUIDEWIRE (STRYKER).
• Patient Sex: Unknown
• Patient Race: Asian