Cook G13815Recalls & reported problems
Cook Incorporated · Standard Wire Guide · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002138155), received between May 10, 2024 and May 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Accessory Incompatible” (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.
Reports received per month
Most reported problems
Device problems
- Accessory Incompatible1
- Collapse1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2024Accessory Incompatible; Collapse; Accessory Incompatible; Collapse
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK STANDARD WIRE GUIDE. IT WAS INITIALLY REPORTED THAT WHEN PERFORMING A WIRE EXCHANGE, THE COIL OF THE WIRE BECAME UNSPOOLED. AS A RESULT, THE ENTIRE WIRE BECAME STRETCHED FURTHER. A NEW DEVICE (LOT NUMBER UNKNOWN) WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 17 APR 2024: IT [COATING DAMAGE] WAS ON PATIENT END [WHEN] IT MALFUNCTIONED. [SUBJECT OF REPORT} A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19287305 ↗
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- Jagwire M00556580Boston Scientific Corporation · Endoscopic guidewire, gastroenterology-urology1 death49 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.