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

Catalog Number	M003XT2750810
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During analysis, the subject catheter tip and shaft was flattened.The subject catheter shaft was kinked proximally which would have caused issues delivering and advancing the stent during the procedure.The catheter was flushed and a 0.0265" patency mandrel was advanced, severe friction was felt throughout the shaft.There was material on the end of the patency mandrel which appeared to be ptfe (polytetrafluoroethylene)) inner lining peeling which most likely occurred when friction was encountered during the procedure and during analysis.The device was being used in a stenosis case which may have contributed to the event.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 as reported event was confirmed based on analysis.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicated that the device was prepared for use as per the directions for use, continuous flush was maintained throughout the clinical procedure and the the patients anatomy was moderately tortuous.Left internal carotid artery (ica) tail severely stenosis case.Length of stenosis was about 1.4cm.The operator used a guidewire and microcatheter to super select to the location and then used balloon catheter to pre-dilate.Then the operator flushed and delivered a stent to go into the subject catheter but resistance was encountered during delivery and when it reached distal of the subject catheter resistance became bigger.The stent could not be advanced or retracted.The operator withdrew the subject catheter together with the stent out of patient's body and checked it and the stent was unexpectedly deployed outside the subject catheter and patient's body.Then the operator found tip of the subject catheter was also deformed.Then replaced them with new catheter and new stent to finish the procedure.The as reported catheter shaft friction, catheter tip damaged and catheter hub friction as well as the analysed catheter shaft kinked/bent, catheter shaft flat/crushed, catheter tip flat/crushed, catheter shaft friction and catheter ptfe inner lining peeling will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the subject catheter polytetrafluoroethylene (ptfe) inner lining appeared to be peeling.No clinical consequences were reported to the patient due to this event.

• 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: 20560441
• Report Number: 3008881809-2024-00514
• Device Sequence Number: 8865696
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: (01)04546540698131(17)261006(10)24558398
• 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): 10/29/2024

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: 24558398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2023
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC); NEUROFORM EZ STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: Asian