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 11/06/2023

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.During visual inspection the subject catheter shaft was seen to be kinked in the mid-section.The catheter shaft was seen to be flat towards the distal end of the catheter.There was no damage note to the catheter hub.There was no damage noted to the catheter tip.There was polytetrafluoroethylene (ptfe) noted 1cm from the top of the catheter hub.During the functional inspection an attempt to flush the micro catheter failed so a 0.0158" patency mandrel was advanced through the sl10 with severe friction noted roughly 1 cm from the tip of the hub.The device could not be flushed so the subject catheter was soaked in warm water for approximately 10 minutes.T he device could still not be flushed so it was cut 1cm from the top of the hub and ptfe 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.No additional information was received from the customer.The catheter shaft was found to be kinked and flattened.The catheter could not be flushed and the patency mandrel could not be advanced.The catheter shaft was cut as the patency mandrel would only advance 1cm into the catheter.There was material removed from the catheter shaft which appeared to be ptfe lining of the catheter.The ptfe would have been damaged when the resistance was encountered during the procedure and during analysis.The as reported event of the catheter, difficulty advancing coil as well as the as analyzed damage of the catheter shaft blocked/occluded, catheter shaft flat/crushed, catheter shaft kinked/bent and catheter ptfe inner lining peeling 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 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) polytetrafluoroethylene (ptfe) coating was peeling.The procedure was completed successfully and 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: 18713163
• MDR Text Key: 336318762
• Report Number: 3008881809-2024-00065
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: 24035950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• 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