EMERALD
Report
- Report Number
- 1016427-2025-00092
- Event Type
- Injury
- Date Received
- December 5, 2025
- Date of Event
- November 5, 2025
- Report Date
- January 30, 2026
- Manufacturer
- CORDIS US CORP.
- Product Code
- DQX
- UDI-DI
- 10705032055031
- PMA / PMN Number
- K864058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, THE DISTAL SECTION OF A .035-INCH 3MM 260CM EMERALD GUIDEWIRE RUPTURED (FRAYED) DURING A CORONARY ANGIOGRAPHY PROCEDURE. MANUAL INTERVENTION WAS PERFORMED AS THE RIGHT RADIAL ARTERY WAS PERFORATED AND TREATED WITH EXTERNAL COMPRESSION. A 6F NON-CORDIS INTRODUCER WAS INSERTED. ANOTHER EMERALD WAS USED TO COMPLETE THE PROCEDURE USING A CONTRALATERAL APPROACH. THE SEPARATED PIECE WAS REMOVED BY PULLING, AND THE PIECE DID NOT FULLY DETACH FROM THE GUIDEWIRE. DURING USE, SLIGHT TORTUOSITY OF THE VESSEL WAS OBSERVED, AND THE GUIDEWIRE WAS ADVANCED WITH SUPPORT FROM A CORDIS JUDKIN¿S LEFT (JL) 3.5 DIAGNOSTIC CATHETER. RESISTANCE WAS ENCOUNTERED AT THE ELBOW, PROMPTING DEVICE REMOVAL AND ANGIOGRAPHIC ASSESSMENT, WHICH REVEALED RUPTURE OF THE GUIDEWIRE AND A TEAR OF THE ARTERY. THE LEFT RADIAL ARTERY WAS THEN ACCESSED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE WIRE WAS REMOVED FROM THE DISPENSER BY ITS DISTAL FLOPPY END, AND THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). GUIDEWIRE MANIPULATION AND TORQUING WERE PERFORMED UNDER FLUOROSCOPIC GUIDANCE, AND RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL. THE DEVICE WAS USED IN HIGHLY TORTUOUS VASCULATURE IN THE RIGHT RADIAL ARTERY AND ALSO ON SMALL SIDE BRANCHES IN THE SAME REGION. THE GUIDEWIRE WAS NOT EXPOSED TO A METAL DEVICE. VESSEL CHARACTERISTICS INCLUDED SMALL CALCIFICATION, TORTUOSITY, NO STENOSIS, AND AN ACUTE ANGLE WITHOUT BIFURCATION. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO DEVICE DAMAGE WAS NOTED PRIOR TO OPENING THE PACKAGE. THE PATIENT WAS NOT HOSPITALIZED NOR WAS THE HOSPITALIZATION EXTENDED DUE TO THE EVENT. THE DGW .035 FC J3MM 260CM TEF GUIDEWIRE WAS RECEIVED COILED INSIDE A CLEAR PLASTIC BAG AND WAS UNPACKED FOR VISUAL INSPECTION. EXAMINATION IDENTIFIED A SINGLE KINK LOCATED APPROXIMATELY 4 CM FROM THE DISTAL TIP, WITH THE DISTAL TIP OF THE CORE WIRE PROTRUDING BETWEEN THE COIL WIRE AT THE KINK LOCATION. NO OTHER ABNORMAL CONDITIONS WERE OBSERVED. THE AREA OF CORE WIRE PROTRUSION WAS FURTHER EVALUATED USING A VISION SYSTEM, WHICH CONFIRMED THAT THE DISTAL TIP OF THE CORE WIRE WAS EXPOSED DUE TO THE WIRE BEING OVERSTRETCHED BEYOND ITS INTENDED MECHANICAL LIMIT. THE KINKED AND UNRAVELED CONDITION WAS CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE. THE EXPOSED DISTAL TIP EXHIBITED A ROUNDED, SMOOTH SURFACE WITH NO EVIDENCE OF SHARP EDGES. THE GUIDEWIRE WAS DISSECTED TO FURTHER ASSESS THE CONDITION OF THE CORE WIRE, AND INSPECTION OF BOTH THE FLEXIBLE CORE WIRE AND CORE WIRE REVEALED NO FRACTURES OR SEPARATIONS. OVERALL EVALUATION DETERMINED THAT THE OBSERVED CONDITION IS CONSISTENT WITH EXCESSIVE FORCE AND DOES NOT PROVIDE EVIDENCE TO SUGGEST A RELATIONSHIP TO THE MANUFACTURING OR DESIGN PROCESS. THE REPORTED ¿DISTAL TIP ¿ FRAYED/SPLIT/TORN¿ WAS NOT FOUND DURING THE PRODUCT EVALUATION AND THE ROOT CAUSE OF ADVERSE EVENT ¿PERFORATION¿ CANNOT BE FOUND WITHOUT PROCEDURAL FILMS. HOWEVER, THE MALFUNCTION ¿GUIDEWIRE ¿ EXPOSED BRAIDWIRE/COREWIRE¿ WAS OBSERVED AND WAS CAUSED BY THE WIRE BEING OVERSTRETCHED BEYOND ITS INTENDED MECHANICAL LIMIT. THE KINKED AND UNRAVELED CONDITION WAS CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE. ADDITIONALLY, THE DEVICE WAS USED IN HIGHLY TORTUOUS VASCULATURE IN THE RIGHT RADIAL ARTERY AND ALSO ON SMALL SIDE BRANCHES IN THE SAME REGION THEREFORE PROCEDURAL AND/OR HANDLING FACTORS RELATED FACTORS CANNOT BE EXCLUDED. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCT¿S LABELING WITH THE INTENT OF MAKING THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ¿CAUTION: WHEN THE GUIDEWIRE IS IN A VESSEL, DO NOT ADVANCE THE MOVABLE CORE IF THE TIP IS IN A CURVED SHAPE. NEVER TWIST OR FORCE THE CORE BECAUSE EXCESSIVE FORCE MAY CAUSE IT TO PENETRATE THE COIL AND DAMAGE THE VESSEL.¿ BASED ON THE AVAILABLE INFORMATION AND PRODUCT ANALYSIS, THERE IS NO EVIDENCE TO SUGGEST THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AS REPORTED, THE DISTAL SECTION OF A .035-INCH 3MM 260CM TEFLON-COATED DGW GUIDEWIRE RUPTURED DURING A CORONARY ANGIOGRAPHY PROCEDURE. MANUAL INTERVENTION WAS PERFORMED AS THE RIGHT RADIAL ARTERY WAS PUNCTURED AND A 6F NON-CORDIS INTRODUCER WAS INSERTED. DURING USE, SLIGHT TORTUOSITY OF THE VESSEL WAS OBSERVED, AND THE GUIDEWIRE WAS ADVANCED WITH SUPPORT FROM A NON-CORDIS JUDKIN¿S LEFT (JL) 3.5 DIAGNOSTIC CATHETER. RESISTANCE WAS ENCOUNTERED AT THE ELBOW, PROMPTING DEVICE REMOVAL AND ANGIOGRAPHIC ASSESSMENT, WHICH REVEALED RUPTURE OF THE GUIDEWIRE AND A TEAR OF THE ARTERY. THE LEFT RADIAL ARTERY WAS THEN ACCESSED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE DEVICE WILL BE RETURNED FOR EVALUATION.
AS REPORTED, THE DISTAL SECTION OF A .035-INCH 3MM 260CM TEFLON-COATED DGW GUIDEWIRE RUPTURED (FRAYED) DURING A CORONARY ANGIOGRAPHY PROCEDURE. MANUAL INTERVENTION WAS PERFORMED AS THE RIGHT RADIAL ARTERY WAS PUNCTURED AND A 6F NON-CORDIS INTRODUCER WAS INSERTED. ANOTHER DGW WAS USED TO COMPLETE THE PROCEDURE AND THAT A CONTRALATERAL APPROACH WAS PERFORMED. THE SEPARATED PIECE WAS REMOVED BY PULLING, AND THE PIECE DID NOT FULLY DETACH FROM THE GUIDEWIRE. DURING USE, SLIGHT TORTUOSITY OF THE VESSEL WAS OBSERVED, AND THE GUIDEWIRE WAS ADVANCED WITH SUPPORT FROM A CORDIS JUDKIN¿S LEFT (JL) 3.5 DIAGNOSTIC CATHETER. RESISTANCE WAS ENCOUNTERED AT THE ELBOW, PROMPTING DEVICE REMOVAL AND ANGIOGRAPHIC ASSESSMENT, WHICH REVEALED RUPTURE OF THE GUIDEWIRE AND A TEAR OF THE ARTERY. THE LEFT RADIAL ARTERY WAS THEN ACCESSED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE WIRE WAS REMOVED FROM THE DISPENSER BY ITS DISTAL FLOPPY END, AND THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). GUIDEWIRE MANIPULATION AND TORQUING WERE PERFORMED UNDER FLUOROSCOPIC GUIDANCE, AND RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL. THE DEVICE WAS USED IN HIGHLY TORTUOUS VASCULATURE IN THE RIGHT RADIAL ARTERY AND ALSO ON SMALL SIDE BRANCHES IN THE SAME REGION. THE GUIDEWIRE WAS NOT EXPOSED TO A METAL DEVICE. VESSEL CHARACTERISTICS INCLUDED SMALL CALCIFICATION, TORTUOSITY, NO STENOSIS, AND AN ACUTE ANGLE WITHOUT BIFURCATION. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO DEVICE DAMAGE WAS NOTED PRIOR TO OPENING THE PACKAGE. THE PATIENT WAS NOT HOSPITALIZED NOR WAS THE HOSPITALIZATION EXTENDED DUE TO THE EVENT. THE DEVICE WAS RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2876813 | EMERALD | WIRE, GUIDE, CATHETER | DQX | CORDIS US CORP. | 35273087 | 10705032055031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 6 FR INTRODUCER.| JL3.5 DIAGNOSTIC CATHETER. |