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

Catalog Number M0031681890

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  malfunction  

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.The device was returned and the product identification was confirmed with the device hub.During visual inspection, there were no visual anomalies noted to the proximal catheter shaft in the location where the stent was stuck.During the functional inspection the microcatheter shaft was flushed without difficulty.A 0.0158" patency mandrel was advanced into the proximal end of the catheter.It met resistance at 35mm from the proximal end of the microcatheter shaft hub.The patency mandrel was next advanced from the distal end of the microcatheter in an attempt to remove the stent from the proximal end of the microcatheter.The stent was removed without difficulty.There was deformation noted to the stent as it was removed through the hub.There was what appears to be polytetrafluoroethylene (ptfe) from the catheter inner layer noted to be wrapped around the distal end of the stent.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 device within specification' was not confirmed during 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.The device was confirmed to be in good condition prior to use on the patient and continuous flush was maintained throughout the clinical procedure.The patients anatomy was described as 'moderately tortuous'.It was reported that 'during an aneurysm embolization procedure with an adjunctive stent through an catheter, the stent was stuck in the microcatheter after a few centimeters from the hub.The operator chose to remove the catheter with the stent stuck inside and proceed with the procedure with another catheter and another stent'.The stent was returned deployed inside catheter shaft, approximately 35mm from the proximal end of the shaft.There was no damage visible to the outside of the catheter shaft.The stent was removed through the microcatheter hub by advancing a patency mandrel through the distal end of the catheter.Once removed it was noted that the distal end of the stent was covered with what appeared to be a layer of ptfe from the inner lumen of the catheter.Once this layer was removed the distal end of the stent was observed to be deformed.It is likely the ptfe inner layer was damaged when resistance was felt advancing the stent in the catheter shaft.The proximal (closed cell) end of the stent was also deformed.The concurrent stent was found to be deformed during analysis which could have contributed to the event.There was no visual damage noted to the catheter.The as analyzed defect of the 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.The as reported event of the device within specification will be assigned not confirmed as the ptfe inner lining was found to have been damaged and there was catheter shaft friction noted during analysis.

Event Description

The device was returned for analysis and the investigation of the device revealed that the catheter (subject device) ptfe coating was peeling.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR SL-10 STRAIGHT 2 TIP 150CM
• Type of Device: 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: 17734506
• MDR Text Key: 323255872
• Report Number: 3008881809-2023-00463
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: 04546540688217
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K013789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0031681890
• Device Lot Number: 24010958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1