CONQUEST PRO
Report
- Report Number
- 3003775027-2025-00012
- Event Type
- Injury
- Date Received
- January 28, 2025
- Date of Event
- September 2, 2020
- Report Date
- January 28, 2025
- Manufacturer
- ASAHI INTECC CO., LTD.
- Product Code
- DQX
- PMA / PMN Number
- K171933
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE IDENTIFIED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. THE REPORTED CONQUEST PRO GUIDE WIRE IS DISTRIBUTED AS CONFIANZA PRO (K171933) IN THE US. AS THE INFORMATION IN THIS REPORT WAS ENTIRELY BASED ON LITERATURE, WHICH DID NOT PROVIDE SUCH DETAILED DEVICE INFORMATION AS LOT NUMBER OR UNIQUE DEVICE IDENTIFIER (UDI), NO OTHER INFORMATION THAN THE BRAND NAME COULD BE OBTAINED. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICES WERE NOT RETURNED. LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED BECAUSE LOT INFORMATION WAS UNAVAILABLE. ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS AND SATISFIED THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA; THEREFORE, IT WAS CONCLUDED THAT THERE WAS NO ANOMALY IN PRODUCT QUALITY. BASED ON THE LITERATURE AND REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT THE CONQUEST PRO GUIDE WIRE MIGHT HAVE BEEN TRAPPED BY TORTUOUS VESSEL OR LESION DUE TO EXCESSIVE WIRE MANIPULATION OR KNUCKLE WIRE. CONSEQUENTLY, DIFFICULTY WAS MET DURING REMOVAL. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS]: OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP. OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR VESSEL TRAUMA MAY OCCUR. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE. NEVER PUSH, AUGER, WITHDRAW, OR TORQUE THIS GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING THIS GUIDE WIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR TIP SEPARATION OF THIS GUIDE WIRE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE. IF THE PROLAPSE OF THE GUIDE WIRE TIP IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE, DAMAGE TO THE GUIDE WIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. IF RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDE WIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDE WIRE ITSELF. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. [MALFUNCTION AND ADVERSE EFFECTS]. REMOVAL DIFFICULTY OF GUIDE WIRE.
IT WAS REPORTED THROUGH LITERATURE THAT ASAHI GUIDE WIRES: RG3 GUIDE WIRE, FIELDER XT-A GUIDE WIRE, ULTIMATEBROS 3 GUIDE WIRE, GAIA SECOND GUIDE WIRE, GAIA THIRD GUIDE WIRE, CONQUEST PRO GUIDE WIRE, CORSAIR PRO MICROCATHETER AND CARAVEL MICROCATHETER WERE TRAPPED IN PATIENT ANATOMY, REQUIRING ADDITIONAL TREATMENTS. PUBLICATION: EUROINTERVENTION 2021;17: 212-219. TITLE: DEVICE ENTRAPMENT DURING PERCUTANEOUS CORONARY INTERVENTION OF CHRONIC TOTAL OCCLUSIONS: INCIDENCE AND MANAGEMENT STRATEGIES. EXCERPT: [METHODS]: PATIENT POPULATION: WE COLLECTED DATA ON 2,361 CONSECUTIVE CTO PCI PROCEDURES PERFORMED BY FIVE HIGH-VOLUME CTO OPERATORS (>100 CASES PER YEAR) IN ITALY BETWEEN JANUARY 2015 AND JANUARY 2020 TO IDENTIFY CASES OF DEVICE ENTRAPMENT. DATA WERE RETROSPECTIVELY COLLECTED FROM EACH CENTRE'S DATABASE. NO EXCLUSION CRITERIA WERE APPLIED. INFORMATION WAS OBTAINED FROM MEDICAL RECORDS AND ANGIOGRAMS. [RESULTS]: A TOTAL OF 2,361 CONSECUTIVE CTO PCI PERFORMED BY FIVE HIGH-VOLUME CTO OPERATORS IN ITALY WERE REVIEWED. THE APPROACH WAS ANTEGRADE IN 1,486 CASES (62.9%) AND RETROGRADE IN 875 CASES (37.1%). DEVICE ENTRAPMENT OCCURRED IN 36 CASES (1.5%). ENTRAPPED DEVICES CONSISTED OF GUIDEWIRES (N=13, 0.5% OF CASES), MICROCATHETERS (N=6, 0.2%), BALLOONS (N=6, 0.2%), ROTATIONAL ATHERECTOMY BURRS (N=10, 0.4%) AND ONE GUIDE CATHETER EXTENSION (N=1; 0.04%). TABLE 3 SHOWS THE TYPES OF DEVICES, CAUSES LEADING TO THE ENTRAPMENT, RETRIEVAL TECHNIQUES AND OUTCOME. NINETEEN CASES OF DEVICE ENTRAPMENT OCCURRED DURING ANTEGRADE CTO PCI AND SEVENTEEN DURING A RETROGRADE APPROACH, WITH NO SIGNIFICANT DIFFERENCES BETWEEN GROUPS (1.3% VS 1.9%, P=0.203). THE MOST COMMON ENTRAPPED DEVICES DURING ANTEGRADE CTO PCI WERE ROTATIONAL ATHERECTOMY BURRS (N=6) AND BALLOONS (N=6), WHILE GUIDEWIRES (N=8) WERE THE MOST FREQUENT ENTRAPPED DEVICES DURING RETROGRADE CTO PCI. DEVICE ENTRAPMENT MANAGEMENT: MANAGEMENT TECHNIQUES OF DEVICE ENTRAPMENT ARE SUMMARIZED IN FIGURE 1 AND TABLE 3. PERCUTANEOUS RETRIEVAL OF THE ENTRAPPED DEVICES WAS ACHIEVED IN 35 OUT OF 36 CASES (97.2%): COMPLETE RETRIEVAL WAS ACHIEVED IN 23 (63.9%) CASES, WHILE PARTIAL RETRIEVAL OF THE ENTRAPPED MATERIAL WAS ACHIEVED IN 12 PATIENTS (33.3%). AMONG THE 13 ENTRAPPED GUIDEWIRES, ONE WAS COMPLETELY RETRIEVED USING THE TRAPPING BALLOON TECHNIQUE. IN THREE CASES, A CLEAN "CONTROLLED RUPTURE" WAS ACHIEVED, AND THE GUIDEWIRE'S TIPS WERE COMPLETELY COVERED AFTER STENT IMPLANTATION. IN EIGHT CASES, RETRIEVAL ATTEMPTS LED TO AN UNFOLDING OF THE TIP COIL INTO SMALL FILAMENTS AND A SNARE WAS REQUIRED TO REMOVE THE FOREIGN BODY; RESIDUAL UNRAVELLED FRAGMENTS WERE SUCCESSFULLY COVERED WITH A STENT IN SEVEN PATIENTS. HOWEVER, INCOMPLETE COVERAGE OF THE UNRAVELED SEGMENT OCCURRED IN ONE CASE DUE TO THE GUIDEWIRE UNRAVELLING INTO A SEPTAL BRANCH. FINALLY, ONE PATIENT REQUIRED EMERGENT SURGERY DUE TO FAILURE TO RETRIEVE A RETROGRADE RG3 WIRE (ASAHI INTECC, AICHI, JAPAN) THAT BECAME ENTRAPPED IN A BIOLOGICAL AORTIC VALVE PROSTHESIS. AMONG THE 6 CASES OF MICROCATHETER ENTRAPMENT, 5 TOOK PLACE DURING A RETROGRADE CTO PCI. IN 4 CASES THE ENTRAPMENT OCCURRED IN SMALL SHARPLY ANGULATED COLLATERAL BRANCHES. SUCCESSFUL RETRIEVAL WAS ACHIEVED BY CUTTING THE MICROCATHETER SHAFT AND ADVANCING A GUIDE CATHETER EXTENSION OVER THE SHAFT, FOLLOWED BY GENTLE PULLING OF THE ENTRAPPED MICROCATHETER. IN 1 CASE, A TIP FRACTURE OF THE MICROCATHETER (CORSAIR) OCCURRED WITHIN A VERY CALCIFIED CTO LESION DURING AN IPSILATERAL (SEPTAL-SEPTAL) RETROGRADE APPROACH. THE GUIDE- WIRE GOT STUCK WITHIN THE FRACTURED MICROCATHETER TIP, ALLOWING A SUCCESSFUL RETRIEVAL OF THE FRAGMENT BY PULLING THE RETROGRADE WIRE. THE ONLY CASE OF MICROCATHETER ENTRAPMENT THAT OCCURRED DURING AN ANTEGRADE APPROACH WAS CHARACTERISED BY MICROCATHETER TIP FRACTURE WITHIN THE CTO BODY. A BALLOON ANGIOPLASTY AROUND THE ENTRAPPED FRAGMENT MANAGED TO FREE THE TIP, ALLOWING ITS SUCCESSFUL RETRIEVAL WITH A SNARE. TABLE 3. DEVICE TECHNICAL FEATURES, CAUSES LEADING TO DEVICE ENTRAPMENT, RETRIEVAL TECHNIQUES AND CLINICAL OUTCOMES. GUIDEWIRES (N=13). DEVICE SPECIFICATION: FIELDER XT-A (N=1), ULTIMATEBROS 3 (N=1), GAIA SECOND (N=5), GAIA THIRD (N=3), CONQUEST PRO (N=2), RG3 (N=1). ENTRAPMENT CAUSE: EXCESSIVE TORQUE (N=7), AGGRESSIVE MANIPULATION (N=2), KNUCKLE WIRE (N=3), BIOLOGICAL AORTIC VALVE ENGAGEMENT (N=1). RETRIEVAL TECHNIQUE: TRAPPING BALLOON TECHNIQUE (N=1), CONTROLLED RUPTURE (N=3), SNARING (N=9) FINAL RESULT: COMPLETE RETRIEVAL (N=1), "CLEAN" FRAGMENT STENTING (N=3), UNRAVELLED FRAGMENT SNARING AND STENTING (N=8), FAILURE TO RETRIEVE (N=1). MACCE: MYOCARDIAL INFARCTION (N=1), URGENT SURGERY (N=1). MICROCATHETERS (N=6). DEVICE SPECIFICATION: CORSAIR (N=1), CORSAIR PRO (N=2), CARAVEL (N=3). ENTRAPMENT CAUSE: CALCIFIED LESION (N=2), THIN AND TORTUOUS COLLATERAL CHANNEL TRACKING (4). RETRIEVAL TECHNIQUE: SHAFT CUTTING AND TELESCOPING GCE (N=4), STRONG TRACTION (N=1), BALLOON ANGIOPLASTY AND SNARING (N=1). FINAL RESULT: COMPLETE RETRIEVAL (N=6). MACCE: MYOCARDIAL INFARCTION (N=2). RG3: MFR REPORT#: 3003775027-2025-00007, FIELDER XT-A: MFR REPORT#: 3003775027-2025-00008, ULTIMATEBROS 3: MFR REPORT#: 3003775027-2025-00009, GAIA SECOND: MFR REPORT#: 3003775027-2025-00010, GAIA THIRD: MFR REPORT#: 3003775027-2025-00011, CORSAIR: MFR REPORT#: 3003775027-2025-00013, CORSAIR PRO: MFR REPORT#: 3003775027-2025-00014, CARAVEL: MFR REPORT#: 3003775027-2025-00015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2587801 | CONQUEST PRO | PTCA GUIDE WIRE | DQX | ASAHI INTECC CO., LTD. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |