MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD PRE-SHAPED 150CM; CATHETER, PERCUTANEOUS

Model Number	M003XT2750910
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
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 visual/microscopic inspection, the catheter shaft was seen to be kinked/bend 148cm from the catheter hub.The catheter shaft was seen to be flat/crushed 146cm from the catheter.The catheter tip and hub were both intact.During functional inspection, a 0.027" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.The microcatheter was difficult to flush, but an attempt was still made to advance a patency mandrel.The mandrel would not advance past 5cm from the catheter hub, an attempt was then made to advance the mandrel distally through the catheter again with resistance felt 5cm from the catheter hub.To determine what was causing the blockage the catheter was cut at this point and again the mandrel was attempted to be advanced through the hub this time pushing out ptfe inner lining.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 specification 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 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 microcatheter was flattened and kinked which would have caused difficulty advancing the stent during the procedure.The ptfe inner lining most likely peeled due to the friction caused trying to insert the stent into the catheter.The microcatheter most likely was damaged 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 as reported ¿catheter hub friction¿ and as analyzed ¿catheter shaft kinked/bent¿, ¿catheter shaft flat/crushed¿, ¿catheter shaft blocked/occluded¿ and ¿catheter ptfe inner lining peeling¿.
Event or Problem Description
Analysis of the returned device found that the ptfe inner lining of subject microcatheter was peeled during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

• Brand Name: EXCELSIOR XT-27 STD PRE-SHAPED 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: 16440536
• Report Number: 3008881809-2023-00084
• Device Sequence Number: 17992262
• Product Code: DQY
• UDI-Device Identifier: 04546540698155
• UDI-Public: 04546540698155
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 02/24/2023

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: 08/14/2025
• Device Model Number: M003XT2750910
• Device Catalogue Number: M003XT2750910
• Device Lot Number: 23809719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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: NEUROFORM EZ STENT SYSTEM (STRYKER)
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Race: Asian