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Jagwire M00556620Recalls & reported problems

Boston Scientific Corporation · High Performance Guidewire · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729747284), received between Jun 22, 2020 and Jun 22, 2020 — classified as 1 injury.

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

Device problems

  • Break1
  • Use of Device Problem1

Patient problems

  • Septic Shock1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 22, 2020Break; Use of Device Problem; Break; Use of Device Problem

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A LITHOTRIPSY (STONE REMOVAL) PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN HOWEVER IT WAS PERFORMED IN EARLY (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE COREWIRE BROKE AND ABOUT 5MM REMAINED IN THE LIVER (S3.) AT THE END (B)(6), EXACT DATE IS UNKNOWN, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL DUE TO SEPTIC SHOCK. REPORTEDLY, IT IS UNKNOWN IF THE JAGWIRE CONTRIBUTED TO THE SEPTIC SHOCK AND IN ADDITION, THE JAGWIRE GUIDEWIRE WAS USED PAST ITS EXPIRY DATE.

    Patient problems: Septic Shock

    MAUDE report 10181657 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.