MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSOR; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number M0066703080

Device Problems Difficult to Insert (1316); Material Separation (1562)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

When surgical tech was handed guidewire after failed stent insertion, surgical tech noted that the guidewire being used was pulling apart.Surgical tech notified surgeon, new guidewire was requested and used for stent insertion.X-ray verification was done as requested by surgeon to verify that no guidewire was retained.

• Brand Name: SENSOR
• Type of Device: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 16408221
• MDR Text Key: 309867452
• Report Number: 16408221
• Device Sequence Number: 1
• Product Code: EZB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M0066703080
• Device Lot Number: 30410192
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Male