CORSAIR PRO
Report
- Report Number
- 3003775027-2025-00014
- 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
- DQY
- 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. 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. AS DESCRIBED IN THE LITERATURE, IT WAS PRESUMED THAT REMOVAL DIFFICULTY OF THE CORSAIR PRO MICROCATHETER WAS CAUSED BY CALCIFIED LESION OR THIN AND TORTUOUS COLLATERAL CHANNEL. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] IF ANY RESISTANCE OR SOMETHING ABNORMAL IS FELT WHEN OPERATING THIS MICROCATHETER, DO NOT CONTINUE THE MANIPULATION WHILE THE CAUSES ARE UNCLEAR. IF IT IS SUSPECTED THAT THIS MICROCATHETER IS NOT OPERATING CORRECTLY, AVOID EXCESSIVE MANIPULATIONS, AND CAREFULLY REMOVE THE ENTIRE CATHETER SYSTEM WHILE PAYING FULL ATTENTION TO AVOID COMPLICATIONS. (CONTINUING THE MANIPULATION WHILE THE CAUSE OF THE PROBLEM IS NOT IDENTIFIED MAY CAUSE DAMAGE TO THIS MICROCATHETER, AND DAMAGE THE BLOOD VESSEL.) THIS MICROCATHETER MUST ALWAYS BE OPERATED UNDER HIGH-RESOLUTION FLUOROSCOPIC GUIDANCE. PARTICULAR ATTENTION SHOULD BE PAID WHEN INSERTING OR WITHDRAWING THIS MICROCATHETER INTO OR THROUGH STENOTIC AREAS, AND NARROWER VESSELS THAN THE MICROCATHETER. (ABRASION MAY RESULT IN DAMAGE OF THIS MICROCATHETER. THIS MAY CAUSE VASCULAR INJURY AND PERFORATION.) [MALFUNCTION AND ADVERSE EFFECTS] WITHDRAWAL DIFFICULTY.
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 DEVICE, 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 CONQUEST PRO: MFR REPORT #: 3003775027-2025-00012 CORSAIR: MFR REPORT #: 3003775027-2025-00013 CARAVEL: MFR REPORT #: 3003775027-2025-00015
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2587802 | CORSAIR PRO | PERCUTANEOUS CATHETER | DQY | ASAHI INTECC CO., LTD. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |