Sensor M0066703010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729752837), received between Oct 24, 2019 and Aug 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING UNPACKING, THE COATING ON ONE END OF THE GUIDEWIRE WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED. INVESTIGATION RESULTS REVEALED THAT THE SLEEVE WAS DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20045676 ↗
• InjuryAug 10, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED DURING A MASTECTOMY WITH PORTACATH PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, UPON REMOVAL OF THE SENSOR WIRE, THE COREWIRE BROKE. IT REMAINED IN THE INTERNAL JUGULAR VEIN AND WAS PICKED UP ON THE RADIOLOGY EXAMS. THIS REQUIRED A RETURN TO SURGERY FOR REMOVAL. THE FRAGMENT WAS REMOVED INTACT AND WAS APPROXIMATELY TWO INCHES IN LENGTH. THE PATIENT WAS UNDERGOING ANOTHER TYPE OF SURGERY IN ADDITION TO THIS IS PORTACATH PLACEMENT. PER THE IFU THE SENSOR UROLOGICAL GUIDEWIRE IS INTENDED TO FACILITATE THE PLACEMENT OF ENDOUROLOGICAL INSTRUMENTS DURING DIAGNOSTIC OR INTERVENTIONAL PROCEDURES. THESE GUIDEWIRES ARE NOT INTENDED FOR CORONARY ARTERY, VASCULAR OR NEUROLOGICAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198590 ↗
• MalfunctionOct 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE GUIDEWIRE WAS USED IN THE URETHRA, BLADDER, URETER AND KIDNEY DURING A RETROGRADE URS (URETEROSCOPY) PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, WHILE PULLING BACK THE SENSOR WIRE THE BLUE PTFE COATING HAS BEEN DAMAGED AND LOOKS LIKE A SPIRAL. THE PROCEDURE WAS COMPLETED WITH A SECOND SENSOR WIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COIL WIRE BROKEN. PLEASE REFER TO BLOCK H10 FOR FULL INVESTIGATION DETAILS. ADDITIONAL INFORMATION: THERE WAS NO LASER PROCEDURE EXECUTED WHILE THE SENSOR WIRE WAS LOADED OVER THE PIGTAIL STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235469 ↗