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

Model Number	M003C1775ST0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Device was returned for analysis, the device was received and the reported lot number was confirmed from the packaging label.During visual inspection, the catheter was seen to be broken.During functional testing, a mandrel was advanced and felt resistance at the point of damage.The reported complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.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.Additional information provided by the customer indicated that there wasn't any damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient.The damage noted to the device would be indicative of the as reported defect.It was seen that the catheter shaft was broken which would account for the difficulty advancing the stent.This defect was a direct cause of the reported issue.The catheter most likely broke during the procedure due to some procedural/anatomical factors encountered during use leading to the reported and analyzed defects.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to the reported and analyzed events 'catheter hub friction', 'catheter shaft friction' as well as the analyzed ¿catheter shaft broken/fractured during use'.
Event or Problem Description
It was reported that the during the procedure, resistance was felt when guiding the subject catheter to the middle cerebral artery with the guidewire used.Physician then replaced the guidewire with the same product and the procedure was continued.A stent was then inserted into the subject catheter and physician noted there was resistance.Physician felt a strong resistance in front of the target site when attempting to place stent.As physician pushed the stent forward, the tip of the stent was protruding to the outside of the subject catheter in front of the second marker.Physician proceeded to remove the subject catheter and stent from patient.Both devices were replaced with the same products and the procedure continued and was completed successfully with no clinical consequences to the patient.Analysis of the returned subject catheter revealed that the device had fractured during use.Therefore, based on this information the event is deemed reportable and emdr will be filed.

• 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
• MDR Report Key: 11220341
• Report Number: 3008881809-2021-00045
• Device Sequence Number: 11582279
• Product Code: DQY
• UDI-Device Identifier: 07613252714866
• UDI-Public: 07613252714866
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/22/2021

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: 12/30/2021
• Device Model Number: M003C1775ST0
• Device Catalogue Number: M003C1775ST0
• Device Lot Number: 22024438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1