MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Catalog Number M0031681900

Device Problem Peeled/Delaminated (1454)

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

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

This is report 2 of 4.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 visual inspection the returned microcatheter was found to be cut.The operator cut it on the table after the procedure and only part of the catheter was returned.A deployed stent was found inside the catheter shaft.The hub was found to be intact.During the catheter shaft friction functional test the device failed.The device could not be flushed due to friction.A patency mandrel was advanced from the distal end; however, it stuck 10 cm from proximal end.The catheter shaft was cut where the mandrel stuck, and the deployed stent was found inside.On removal of the stent the patency mandrel was advanced through the cut microcatheter shaft and polytetrafluoroethylene (ptfe) and green material was removed.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 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.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.The catheter shaft was returned cut and only part of the catheter was retuned.The patency mandrel was advanced through the catheter and the concurrent stent was removed from the distal part of the cut shaft.The stent was found to be deformed.The catheter device could not be flushed after the stent was removed.The catheter was cut again, green material and ptfe inner lining were removed from the shaft.The green material was most likely from the guidewire used in the procedure.There was no allegation against the guidewire used in the procedure.The most likely cause for the ptfe peeling from the guidewire is the guidewire may have been backloaded through the guidewire introducer to load into the microcatheter hub.The catheter ptfe inner lining was most likely was damaged when friction was felt advancing the stent.The reported and analyzed event of catheter shaft friction as well as the as analyzed damage of the catheter ptfe inner lining peeling and the device difficult to flush will be assigned procedural factors as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and anatomical factors during use, the product performance was limited.

Event Description

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

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 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: 18813340
• MDR Text Key: 336867120
• Report Number: 3008881809-2024-00079
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042568
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0031681900
• Device Lot Number: 24146874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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
• Patient Race: Asian