MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 STRAIGHT 1 TIP 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681810
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device revealed that subject catheter ptfe polytetrafluoroethylene inner lining was peeling.There was no clinical consequence to the patient due to this event.
Additional Manufacturer Narrative
This is 2/2 reports.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 returned cut (as per event description).The catheter shaft was kinked bent.The catheter hub was intact.During functional inspection, a 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.The catheter could not be flushed as the stent was within the shaft.A 0.0158" patency mandrel was advanced into the catheter hub.The patency mandrel advanced 4cm into the hub and would not advance further.The catheter shaft was cut 5.4cm from the proximal of the hub and the stent was identified.The stent was removed with force from the microcatheter shaft.There was what appeared to be polytetrafluoroethylene ptfe inner lining wrapped around the proximal side of the stent.There was what appeared to be ptfe inner lining protruding from the cut microcatheter shaft.Once the stent was removed the mandrel was inserted into the hub and shaft without issue.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 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 and continuous flush was maintained throughout the clinical procedure.It was reported that when inserting the stent delivery wire into the subject microcatheter, resistance was encountered when it passed the hub and strain relief; however, continued to advance the delivery wire.When the fluoro-saver marker came to the proximal, confirmed under the fluoroscopy; however, only the delivery wire tip marker could be seen, and the markers at both ends of the stent were not visible.Thus, the stent was retrieved with the entire microcatheter, and the stent was replaced with a non-stryker stent, then the procedure was completed successfully.Although the sales rep sr did not actually see the device from the side, she confirmed with the physician that the back flush in the delivery sheath had been performed and that the tip of the sheath was completely inserted into the hub of the microcatheter at the insertion.After retrieval of the devices, the proximal end of the microcatheter was cut off with cooper scissors by the operator.When the stent was pushed with a delivery wire from both the cut tip and the hub, resistance was encountered beyond the strain relief, and the stent could not be removed.The device was returned for analysis, and it was noted that the catheter shaft kinked.The catheter could not be flushed as the stent was within the shaft.A 0.0158" patency mandrel was advanced into the catheter hub.The patency mandrel advanced 4cm into the hub and would not advance further.The catheter shaft was cut 5.4cm from the proximal of the hub and the stent was identified.The stent was removed with force from the microcatheter shaft.There was what appeared to be ptfe inner lining wrapped around the proximal side of the stent.There was what appeared to be ptfe inner lining protruding from the cut microcatheter shaft.Once the stent was removed the mandrel was inserted into the hub and shaft without issue.Based on a review of all available information and the analysis of the returned device it is probable that the ptfe inner layer was damaged when resistance was felt advancing the stent during the procedure and during analysis.The stent was advanced after resistance was encountered, as per subject microcatheter dfu "never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the microcatheter or guidewire against resistance could dislodge a clot, perforate a vessel wall, or damage microcatheter and guidewire.In severe cases, tip separation of the microcatheter or guidewire may occur." it is probable the concurrent atlas stent may have been damaged during transfer causing the resistance.The as reported and as analyzed 'catheter shaft friction' 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.The as analyzed 'catheter shaft kinked/bent', 'catheter shaft blocked/occluded' and 'catheter ptfe inner lining peeling' will be assigned use error as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.

• Brand Name: EXCELSIOR SL-10 STRAIGHT 1 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: 21644335
• Report Number: 3008881809-2025-00152
• Device Sequence Number: 18067435
• Product Code: DQY
• UDI-Device Identifier: 04546540688200
• UDI-Public: (01)04546540688200(17)260113(10)24707473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/19/2025

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: 01/13/2026
• Device Catalogue Number: M0031681810
• Device Lot Number: 24707473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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).
• Patient Sex: Unknown