MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSOR NITINOL WIRE WITH HYDROPHILIC STRAIGHT TIP; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number 0.035IN X 150CM

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/29/2016

Event Type  malfunction  

Event Description

Pt had a cystoscopy left ureteroscopy with holmium laser lithotripsy.Surgeon used a sensor wire.Upon follow-up about 10 days later at office visit, surgeon discovered on x-ray, that pt had done and brought to the office appointment, a portion of the tip from a sensor wire.

• Brand Name: SENSOR NITINOL WIRE WITH HYDROPHILIC STRAIGHT TIP
• Type of Device: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• MDR Report Key: 5569494
• MDR Text Key: 42410596
• Report Number: 5569494
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/06/2018
• Device Model Number: 0.035IN X 150CM
• Device Catalogue Number: M0066703051
• Device Lot Number: 18706272
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HOLMIUM LASER LITHOTRIPSY
• Patient Age: 67 YR
• Patient Weight: 62