Cope G05176Recalls & reported problems
Cook Incorporated · Cope Mandril Wire Guide Stainless Steel · Class 2
All models of Cope (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00827002051768), received between Sep 7, 2017 and Sep 7, 2017 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
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.
InjurySep 7, 2017Break; Break
THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING AN ABDOMINAL (MEDIAN) APPROACH OF THE INTRAHEPATIC BILE DUCT WITH A COPE STAINLESS STEEL MANDRIL WIRE GUIDE, THE WIRE GUIDE FRACTURED. THE FRACTURE WAS DISCOVERED UPON THE REMOVAL OF THE WIRE GUIDE FOLLOWING CATHETER PLACEMENT. THE OPERATOR OF THE DEVICE BELIEVED THAT THE RETRIEVAL OF THE PORTION OF WIRE THAT FRACTURED OFF WOULD BE DIFFICULT, AND AS A RESULT THE FRAGMENT WAS LEFT IN THE PATIENT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THE PORTION OF THE WIRE WHICH WAS LEFT IN THE PATIENT. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE ARE NOT KNOWN. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6848676 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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