MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 STRAIGHT 2 TIP 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681890
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2/2 mdrs 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 was returned with a stent deployed within the lumen/hub at the proximal end.The catheter had been cut.The cut section was flushed; some blood was present.There was an unknown material (possibly some sort of tubing like polytetrafluoroethylene ptfe) present on the stent.During functional inspection, the microcatheter shaft was able to be flushed.A 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.A 0.0158" patency mandrel was unable to be completely advanced through the microcatheter.Resistance was met at the distal end due to the presence of dried blood.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 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.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, the device confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.It was reported that while advancing the stent, the physician found that the stent became stuck at the hub of the subject microcatheter and could not be pushed forward.The stent became deployed and remained inside the hub of the microcatheter.During analysis, the catheter was returned with a stent deployed within the lumen/hub at the proximal end.The catheter had been cut.The cut section was flushed; some blood was present.There was an unknown material (possibly some sort of tubing like ptfe) present on the stent.The microcatheter shaft was able to be flushed.A 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.A 0.0158" patency mandrel was unable to be completely advanced through the microcatheter.Resistance was met at the distal end due to the presence of dried blood.Based on a review of all available information and the analysis of the returned device it is probable that there may have been an issue with the flush during the procedure due to the presence of blood in the catheter, causing the stent to have difficulty advancing in the microcatheter.The catheter shaft was most likely damaged during manipulation of the device when the resistance was encountered.An assignable cause of procedural factors will be assigned to the as reported 'catheter hub friction' as well as the as analyzed 'catheter shaft friction', 'catheter ptfe inner lining peeling' and 'catheter shaft blocked/occluded' as these issues are associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
The subject catheter was returned for analysis and the device investigation revealed that the subject catheter ptfe polytetrafluoroethylene inner lining was peeled.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: EXCELSIOR SL-10 STRAIGHT 2 TIP 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: 25047136
• Report Number: 3008881809-2026-00267
• Device Sequence Number: 16066725
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: (01)04546540688217(17)270622(10)25679411
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013789
• 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): 04/30/2026

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: M0031681890
• Device Lot Number: 25679411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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 STENT (STRYKER); SYNCHRO SELECT GUIDEWIRE (STRYKER)
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Race: Asian