CONQUEST PRO 12 ST
Report
- Report Number
- 3003775027-2025-00176
- Event Type
- Injury
- Date Received
- July 16, 2025
- Report Date
- July 16, 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
- JA
- 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 DEVICE IS SOLD OUTSIDE THE US IN A DIFFERENT BRAND NAME BUT IS SIMILAR IN STRUCTURE AND CONSTRUCTION AS A CURRENTLY US MARKETED DEVICE, CONFIANZA PRO 12 (K171933). 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 INFORMATION AND REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT TENSILE STRESS GENERATED WITH REMOVAL MIGHT HAVE BEEN LOCALLY APPLIED ON THE CONQUEST PRO 12 ST GUIDE WIRE WHILE THE GUIDE WIRE HAD BEEN TRAPPED IN THE HEAVILY CALCIFIED LESION. CONSEQUENTLY, THE GUIDE WIRE WAS FRACTURED. 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 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] ~ SEPARATION OF THE GUIDE WIRE.
IT WAS REPORTED THROUGH LITERATURE THAT THE TIP OF AN ASAHI CONQUEST PRO 12 ST GUIDE WIRE HAD FRACTURED AND REQUIRED ADDITIONAL TREATMENT. PUBLICATION: CORONARY INTERVENTION 2025 VOL.21 NO.3 TITLE: A CASE OF SEVERELY CALCIFIED LAD CTO COMPLICATED WITH GUIDEWIRE FRACTURE AND CORONARY ARTERY PERFORATION. EXCERPT: THE PATIENT WAS A FEMALE IN HER 80S. THERE WAS A CHRONIC TOTAL OCCLUSION (CTO) IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AFTER BRANCHING THE SEPTAL BRANCH. SEVERE CALCIFICATION WAS OBSERVED IN THE PROXIMAL LAD AND THE CTO BODY. COLLATERAL BLOOD FLOW WAS OBSERVED FROM THE DIAGONAL BRANCH NEAR THE OCCLUSION. SEVERE STENOSIS OR OCCLUSION WERE OBSERVED IN THE LEFT CIRCUMFLEX ARTERY (LCX) AND THE SIDE BRUNCH. ABLATION WAS PERFORMED USING A ROTABLATOR FROM 1.5 TO 2.0 MM FOR THE CALCIFIED LESION IN THE PROXIMAL LAD AND THE IVUS WAS THEN ADVANCED TO THE DIAGONAL BRANCH. AN ASAHI CORSAIR PRO MICROCATHETER WAS BROUGHT TO THE CTO ENTRY AND AN ASAHI X-TREME XT-R GUIDE WIRE WAS USED TO TRACK THE MICROCHANNEL. THE GUIDE WIRE COULD NOT BE ADVANCED BEYOND THE MIDDLE PART OF THE CTO. THE CORSAIR PRO COULD NOT BE ADVANCED ANY FURTHER FROM THE ENTRY POINT, AND NEITHER A 1.0 MM BALLOON NOR A TERUMO CORPORATION ZIZAI MICROCATHETER COULD PENETRATE INTO THE CTO. THE GUIDEWIRE WAS STEPPED UP FROM AN ASAHI GAIA NEXT 1 GUIDE WIRE TO AN ASAHI GAIA NEXT 2 GUIDE WIRE AND AN ASAHI GAIA NEXT 3 GUIDE WIRE; HOWEVER, NEITHER OF THEM COULD BE ADVANCED THE CALCIFIED CTO, AND THE GAIA NEXT 3 BECAME STUCK. FURTHER USED ASAHI TORNUS PRO MICROCATHTER AND SMALL-DIAMETER BALLOONS ALSO WOULD NOT CROSS THE LESION. FINALLY, A TERUMO KIWAMI CATHETER WAS BROUGHT TO THE PROXIMAL PART, AND THE GUIDE WIRE WAS PULLED WHILE AN ASAHI CORSAIR ARMET MICROCATHETER WAS PUSHED IN; HOWEVER, THE MICRO CONE TIP OF THE GAIA NEXT 3 GUIDE WIRE WAS LEFT BEHIND IN THE CTO ENTRY. THEREFORE, PCI FOR THE CTO IN THE LAD WAS ABANDONED, AND THE PROCEDURE WAS COMPLETED BY PERFORMING PCI FOR THE SEVERE STENOSIS IN THE DIAGONAL BRANCH. AFTER MEDICATION ADJUSTMENT AND CARDIAC REHABILITATION, THE PATIENT'S GENERAL CONDITION IMPROVED AND SHE WAS DISCHARGED FROM THE HOSPITAL, BUT TWO MONTHS LATER SHE WAS READMITTED DUE TO WORSENING HEART FAILURE. DESPITE MEDICAL THERAPY, THERE WAS LITTLE IMPROVEMENT IN HEART FAILURE, SO IT WAS DECIDED TO RETRY THE TREATMENT FOR THE LAD CTO. THE PRESENCE OF COLLATERALS VIA THE SEPTAL BRANCH WAS CONFIRMED BY TIP INJECTION, BUT IT WAS NOT A PROMISING CHANNEL. AN ANTEGRADE APPROACH WAS STARTED, BUT THE MICROCHANNEL THAT HAD EXISTED FROM THE CTO ENTRY HAD DISAPPEARED, AND PENETRATION OF THE PROXIMAL CAP WAS NECESSARY TO ENTER THE CTO. SEVERE FULL-MOON CALCIFICATION WAS OBSERVED AT THE CTO ENTRY AND IT WAS THOUGHT THAT A STIFF WIRE WOULD BE REQUIRED FOR PENETRATION. AFTER WIRING OF THE SEPTAL BRANCH, AN UNSPECIFIED MICROCATHETER AND A SMALL-DIAMETER BALLOON WOULD NOT CROSS THE LESION. THE PHYSICIAN MANAGED TO THREAD A TERUMO FINECROSS MICROCATHETER AND EXCHANGE IT FOR A BOSTON SCIENTIFIC ROTAWIRE. ABLATION WAS THEN PERFORMED WITH ROTABLATORS FROM 1.25 MM TO 1.5 MM. AFTER CONFIRMATION WITH IVUS FROM THE SEPTAL BRANCH, AN ASAHI GAIA NEXT 3 GUIDE WIRE WAS ADVANCED WITH THE SUPPORT OF AN ASAHI SASUKE DUAL LUMEN CATHETER, BUT IT COULD NOT BE ADVANCED ANY FURTHER NEAR THE TIP THAT HAD BEEN LEFT DURING THE PREVIOUS PROCEDURE. AN ASAHI GAIA NEXT 4 GUIDE WIRE WAS THE USED AND ADVANCED THROUGH THE LESION VIA A DIFFERENT ROUTE. THE FINECROSS WAS THEN ADVANCED AND GUIDE WIRE ESCALATION/DE-ESCALATION WAS PERFORMED THROUGH THE FINECROSS, AND THE GUIDE WIRE WAS ADVANCED USING THE CALCIUM AS A LANDMARK. FINALLY, AN ASAHI GAIA NEXT 1 GUIDE WIRE WAS REPELLED BY THE CALCIUM AND A GAIA NEXT 3 GUIDE WIRE WAS ADVANCED AS PARALLEL WIRE TO THE EXIT OF THE CTO. ATTEMPT TO CROSS THE LESION VIA RETROGRADE APPROACH WAS ABANDONED BECAUSE THE SEPTAL CHANNEL FROM THE LCX COULD NOT BE PASSED. THE PHYSICIAN SWITCHED BACK TO THE ANTEGRADE APPROACH AGAIN. CONFIRMATION WITH IVUS FOUND THAT THE GUIDE WIRE WENT IMMEDIATELY TO THE SUB-INTIMAL SPACE AND THEN OUTSIDE THE VESSEL AFTER CROSSING THE CTO ENTRY, BUT THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION OR HEMODYNAMIC COLLAPSE. WIRING WAS PERFORMED USING AN ASAHI GAIA NEXT 4 GUIDE WIRE WITH IVUS GUIDANCE FROM THE SUB-INTIMA (REACHING OUTSIDE THE BLOOD VESSEL), BUT IT HIT THE REMAINED TIP OF GAIA NEXT 3 AND COULD NOT BE ADVANCED. A GUIDE WIRE WAS PLACED IN THE SEPTAL BRANCH. ATTEMPT TO ADVANCE A GAIA NEXT 4 GUIDE WIRE VIA THE SASUKE DUAL LUMEN CATHETER TO THE CTO FROM THE OSTIUM WAS UNSUCCESSFUL. AN ASAHI CONQUEST PRO 12 ST GUIDE WIRE WAS THEN USED, THE TIP OF WHICH GOT TRAPPED AND FRACTURED. A FEW MILLIMETERS OF THE TIP REMAINED IN THE CORONARY ARTERY. DUE TO THE HEAVILY CALCIFIED LESION, IT WAS DETERMINED THAT IT WOULD BE DIFFICULT TO PENETRATE THE OCCLUSION VIA THE INTRA-PLAQUE APPROACH, AND A GUIDE WIRE WAS ADVANCED THROUGH THE SUB-INTIMA INTENDEDLY. DILATION WAS PERFORMED USING A 2.5 X 15MM ASAHI KAMUI BALLOON AND IVUS CONFIRMED THAT A SUB-INTIMAL SPACE HAD BEEN FORMED IN THE LAD. AN ASAHI SION BLACK GUIDE WIRE WAS ADVANCED THROUGH THE SUB-INTIMA USING KNUCKLE WIRE TECHNIQUE. A 2.5 X 15MM ASAHI KAMUI BALLOON WAS INFLATED AND THE DISTAL TRUE LUMEN THAT HAD COLLAPSED FROM THE SUB-INTIMA WAS CONFIRMED. A CONQUEST PRO 12 ST GUIDE WIRE WAS THEN USED FOR TD-ADR AND REACHED THE DISTAL TRUE LUMEN. THE FINECROSS WAS ADVANCED AND THE GUIDE WIRE WAS STEPPED DOWN TO XT-R, WHICH COULD BE ADVANCED TO THE PERIPHERAL LAD. THE FRACTURED TIP OF THE CONQUEST PRO 12 ST MOVED TO THE DIAGONAL BRANCH AND WAS RETRIEVED USING AN ASAHI SOUTENIR. TWO DRUG-ELUTING STENTS (DES) WERE DEPLOYED AND THE PROCEDURE WAS COMPLETED WITH GOOD BLOOD FLOW. GAIA NEXT 3: MFR REPORT #: 3003775027-2025-00175.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 555046 | CONQUEST PRO 12 ST | PTCA GUIDE WIRE | DQX | ASAHI INTECC CO., LTD. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Female | Other| R |