Cope G09593Recalls & reported problems
Cook Incorporated · Cope Mandril Wire Guide Stainless Steel · Class 2
All models of Cope (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00827002095939), received between Mar 15, 2018 and Mar 15, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unraveled Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Unraveled Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2018Unraveled Material; Unraveled Material
THE CUSTOMER REPORTED THAT, UPON UNCAPPING AN EXISTING INTRAVENOUS LINE (IV) IN THE RIGHT ANTECUBITAL (AC) VEIN DURING A RIGHT HEART CATHETERIZATION WITH A RIGHT AC VEIN APPROACH, THE PHYSICIAN NOTED THAT THERE WAS NO BLOOD RETURN. THEY THEN PROCEEDED TO ATTEMPT TO PUT THE COPE STAINLESS STEEL MANDRIL WIRE GUIDE THROUGH THE IV WITH THE ASSISTANCE OF FLUOROSCOPIC IMAGING, BUT THE TIP OF THE WIRE APPEARED TO HAVE BUNCHED UP. WHEN REMOVING THE WIRE, THE PHYSICIAN REPORTED THAT IT FELT AS IF THE WIRE WAS COMING OUT, BUT THE TIP DID NOT APPEAR TO BE MOVING ON THE FLUOROSCOPIC IMAGE. WHEN THE WIRE WAS FINALLY REMOVED, IT WAS DISCOVERED THAT THE TIP HAD UNRAVELED. THE CUSTOMER REPORTED THAT THE WIRE GUIDE HAD BEEN KEPT FLUSHED AND WET WITH HEPARINIZED SALINE. THE CUSTOMER CONFIRMED THAT NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT PROBLEM, AND NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT; HOWEVER, THE PHYSICIAN DID ELECT TO PURSUE FEMORAL ACCESS FOR THE RIGHT HEART CATHETERIZATION, AND THE IV LINE WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FORM THE CUSTOMER, BUT NONE HAS YET BEEN PROVIDED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THI
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7343785 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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