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

Model Number	M003C1775ST0
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
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 the visual inspection, the catheter shaft was seen to be kinked by the distal tip.The catheter shaft was seen to be kinked at different locations from the catheter hub.The catheter shaft was seen to have a hole present and the inner coil wind had protruded through the hole.The catheter tip was seen to be damaged.The catheter hub was intact.Functional inspection, the catheter could not be flushed, a patency mandrel was advanced through without flush and friction was felt advancing through the shaft.The mandrel would not advance any further inside the catheter.An attempt was then made to advance the mandrel distally through the catheter, meeting the same blocked section.The catheter was cut at this point to determine what was causing the blockage, material was removed from the catheter shaft.The material was submerged in water which dissolved confirming solidified contrast media present within the catheter shaft.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 defect was confirmed based on analysis of the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The product was returned, and the as analyzed codes listed in the below product problem code grid were found.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, and the device was confirmed to be in good condition during preparation/prior to use on the patient.Also, additional information indicated that flush was given to the catheter prior to inserting the guidewire.The operator delivered the guidewire to pass the lumen of the catheter outside the patient's body.'the catheter shaft was found to be kinked' , and 'the tip of the catheter was damaged'.The 'catheter shaft has holes/perforation'.The catheter most likely was damaged when force ' catheter shaft friction' was applied trying to advance the guidewire.The 'catheter shaft was found to be blocked and could not be flushed'.There was dried contrast media within the catheter shaft.The complaint 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 factors, the product performance was limited.The as reported as well as the as analyzed listed in the grid below will be assigned procedural factors.
Event or Problem Description
The subject device was returned for analysis and the investigation of the device revealed that the subject catheter shaft has holes/perforation.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• 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: 16676272
• Report Number: 3008881809-2023-00171
• Device Sequence Number: 5435346
• Product Code: DQY
• UDI-Device Identifier: 07613252714866
• UDI-Public: 07613252714866
• 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): 04/04/2023

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: 03/20/2024
• Device Model Number: M003C1775ST0
• Device Catalogue Number: M003C1775ST0
• Device Lot Number: 23551421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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: ATLAS 4-21 STENT (STRYKER); SL-10 MICROCATHETER (STRYKER; SYNCHRO GUIDEWIRE 2 (STRYKER); TARGET 1-1 COIL (STRYKER); TARGET 1.5-3 COIL (STRYKER); TARGET 2-4 COIL (STRYKER)
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: Asian