FIELDER
Report
- Report Number
- 3003775027-2023-00101
- Event Type
- Injury
- Date Received
- October 25, 2023
- Report Date
- July 19, 2024
- Manufacturer
- ASAHI INTECC CO., LTD.
- Product Code
- DQX
- PMA / PMN Number
- K163426
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
**UDI RELATED DATA QUALITY UPDATES ONLY** AS WE RECEIVED AN EMAIL TIME-STAMPED SATURDAY, (B)(6) 2024 9:54 AM AT OUR END FROM (B)(6), MDR DATA SYSTEMS TEAM, TO INFORM US THAT INFORMATION ABOUT THE SUSPECT MEDICAL DEVICES INVOLVED IN THE REPORTED EVENTS, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A WAS MISSING. AFTER COMPARING THE INFORMATION IN THE PREVIOUS SUBMITTED MDR WITH THAT OF FIELDER IN THE CORRESPONDING FIELDS IN THE GUDID, WE DETERMINED TO SUBMIT THIS SUPPLEMENTAL REPORT. THE CHANGES WE INTEND TO MAKE ARE AS FOLLOWS: D1: BRAND NAME - FROM FIELDER TO FIELDER D3: MANUFACTURER NAME, CITY, AND STATE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL # - FROM NA TO NO ENTRY CATALOG # - FROM UNKNOWN TO NO ENTRY SERIAL # - FROM NA TO NO ENTRY LOT # - FROM UNKNOWN TO NO ENTRY PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # - FROM UNKNOWN TO NO ENTRY G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. G1: EMAIL - FROM [email protected] TO [email protected] 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.
MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE IDENTIFIED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS 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. MULTIPLE ASAHI PRODUCTS WERE USED IN THIS STUDY; HOWEVER, HOW EACH MENTIONED PRODUCT HAD CAUSED OR CONTRIBUTED TO MACE WAS UNABLE TO BE DETERMINED BASED ON THE LIMITED WRITTEN INFORMATION. REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT PATIENT ANATOMY AND PROCEDURAL CONTENTS WERE MOST LIKELY ASSOCIATED WITH ADVERSE EVENTS OCCURRED DURING THIS STUDY. 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. ~ USE THIS GUIDE WIRE CAREFULLY AS THE GUIDE WIRE MAY PENETRATE THE BLOOD VESSEL. OTHERWISE, IT MAY CAUSE ADVERSE EVENTS SUCH AS BLOOD VESSEL PERFORATION AND CORONARY ARTERY DISSECTION. THE HIGHER TORQUE PERFORMANCE, STIFFER DISTAL END, AND/OR HIGHER ADVANCEMENT FORCE MAY PRESENT A HIGHER RISK OF PERFORATION OR INJURY THAN IF USING A MORE FLEXIBLE GUIDE WIRE. THEREFORE, USE THE MOST FLEXIBLE GUIDE WIRE THAT WILL TREAT THE LESION (I.E., THE GUIDE WIRE WITH THE SMALLEST TIP LOAD THAT WILL TREAT THE LESION), AND TAKE DUE CARE TO MINIMIZE THE RISK OF PERFORATION OR OTHER DAMAGE TO BLOOD VESSELS. [MALFUNCTION AND ADVERSE EFFECTS] ~ DAMAGE TO A VESSEL, INCLUDING POSSIBLE VESSEL PERFORATION ~ THROMBUS.
IT WAS REPORTED THROUGH LITERATURE THAT ASAHI PRODUCTS: FIELDER GUIDE WIRE, FIELDER FC GUIDE WIRE, MIRACLEBROS 3 GUIDE WIRE, MIRACLEBROS 6 GUIDE WIRE, MIRACLEBROS 12 GUIDE WIRE, CONFIANZA PRO 9 GUIDE WIRE AND CONFIANZA PRO 12 GUIDE WIRE MIGHT HAVE CAUSED OR CONTRIBUTED TO MYOCARDIAL INFARCTION OR PERFORATION. PUBLICATION: JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 2, NO. 9, 2009 SEPTEMBER 2009: 834 - 42 TITLE: RETROGRADE TECHNIQUES AND THE IMPACT OF OPERATOR VOLUME ON PERCUTANEOUS INTERVENTION FOR CORONARY CHRONIC TOTAL OCCLUSIONS, AN EARLY U.S. EXPERIENCE EXCERPT: [METHODS] THIS PRESENT REPORT IS AN OBSERVATIONAL STUDY, BETWEEN JANUARY 2005 AND MARCH 2008, IN WHICH 636 PATIENTS WITH CORONARY CTO HAD PCI ATTEMPTED AT 2 HIGH-VOLUME MEDICAL CENTERS. WE DIVIDED THE OPERATORS INTO 2 GROUPS TO BETTER UNDERSTAND THE EFFECT OF RETROGRADE TECHNIQUE AND CTO-SPECIFIC EXPERIENCE (ANTEGRADE AND RETROGRADE) ON LEARNING CURVE AND OUTCOMES: RETROGRADE OPERATORS (ROS) (>75 TOTAL CTO PCI CASES AND >20 RETROGRADE ATTEMPTS DURING THIS TIME PERIOD) AND NONRETROGRADE OPERATORS (NROS). THE PRIMARY OBSERVATION REPORTED WAS PROCEDURAL TECHNICAL SUCCESS (<50% RESIDUAL STENOSIS AT THE TARGET CTO LESION WITH TIMI ANTEROGRADE FLOW GRADE 3). SECONDARY OBSERVATIONS INCLUDED COMPLICATIONS (DEATH, MYOCARDIAL INFARCTION, MAJOR AND MINOR CORONARY PERFORATION), TECHNICAL SUCCESS RATE BY "INTENDED INITIAL STRATEGY" AS WELL AS "ACTUAL TREATMENT STRATEGY," AND TEMPORAL TRENDS IN SUCCESS AND TREATMENT PATTERNS. PRIMARY RETROGRADE WIRE CROSSING. THE RETROGRADE WIRE WAS USED TO COMPLETELY CROSS THE CTO, BEING ADVANCED UPSTREAM FROM THE DISTAL TRUE LUMEN, THROUGH THE CTO, AND INTO THE PROXIMAL TRUE LUMEN. THIS SUCCESSFULLY PASSED RETROGRADE WIRE WAS THEN USED AS A RAIL FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OF THE LESION. OFTEN, THE WIRE THAT CROSSED THE RETROGRADE COLLATERAL CHANNEL COULD PRIMARILY CROSS THE CTO RETROGRADE. THIS WIRE WAS THEN ADVANCED THROUGH THE CORONARY OSTIUM WELL INTO THE AORTA, OR OPTIMALLY, INTO THE ANTEGRADE GUIDE AND "ANCHORED" WITH AN ANGIOPLASTY BALLOON INFLATED IN THE ANTEGRADE GUIDE (TO FIX THIS WIRE IN POSITION). OCCASIONALLY, THE FLOPPY WIRE USED TO TRAVERSE THE COLLATERALS COULD NOT PENETRATE THE CTO LESION RETROGRADE. IN THIS CASE, IF A PTCA BALLOON COULD BE DELIVERED THROUGH THE COLLATERALS TO THE DISTAL ARTERY, IT WAS INFLATED AS A DISTAL "ANCHOR" AND USED TO EXCHANGE FOR ADVANCED WIRES FOR RETROGRADE CTO PENETRATION AND CROSSING (E.G., MIRACLE BROS 3, 6, 12 G, CONFIANZA PRO 9, 12 G, ALL MANUFACTURED BY ASAHI-INTEC, NAGOYA, JAPAN). DISSECTION TECHNIQUES. CONTROLLED ANTEGRADE AND RETROGRADE TRACKING (CART TECHNIQUE) HAS BEEN A MAJOR ADVANCE IN COMPLEX CORONARY CTO PCI AND PREVIOUSLY DESCRIBED (14). BRIEFLY, ANTEGRADE AND RETROGRADE WIRES WERE ADVANCED INTO THE CTO AND FALSE LUMENS (WHEN THE TRUE LUMEN BEYOND THE CTO LESION COULD NOT BE ACCESSED). A RETROGRADE BALLOON (AFTER ENTIRE SEPTAL DILATION OR IN LARGE EPICARDIAL COLLATERAL) WAS ADVANCED AND DILATED IN THE DISTAL CTO CAP, THUS EXPANDING THE SUBADVENTITIAL/SUBLESIONAL/SUBINTIMAL SPACE. THE ANTEGRADE WIRE (CONFIANZA 9, 12 G, MIRACLE 12 G, FIELDER, ASAHI-INTEC) WAS DIRECTED TOWARD THE RETROGRADE BALLOON AS IT WAS DEFLATED. ONCE THE ANTEGRADE WIRE ENTERED THIS SPACE, IT COULD BE FURTHER ADVANCED BACK INTO THE TRUE LUMEN ALONG THE PATH TAKEN BY THE RETROGRADE BALLOON AND WIRE. [RESULTS] NO SIGNIFICANT DIFFERENCES IN ADVERSE EVENT RATES WERE SEEN WHEN ANALYZING WITH REGARD TO OPERATOR RETROGRADE EXPERIENCE/ VOLUME GROUP CATEGORY, OR LESION TREATMENT WITH THE ANTEGRADE VERSUS RETROGRADE APPROACH. NO IN-HOSPITAL DEATHS WERE SEEN IN EITHER THE RETROGRADE OR ANTEGRADE APPROACH GROUP IN THIS TIME PERIOD, AND RATES OF MYOCARDIAL INFARCTION (3.3% ANTEGRADE VS. 0.8% RETROGRADE, P=NS), SIGNIFICANT PERFORATION (0.97% ANTEGRADE VS. 0.82% RETROGRADE, P=NS), AND OVERALL ADVERSE EVENT (DEATH/MYOCARDIAL INFARCTION/SIGNIFICANT PERFORATION 3.8% ANTEGRADE VS. 1.64% RETROGRADE, P=NS) WERE SIMILAR FOR BOTH APPROACHES. AS SEEN IN TABLE 2, THE RO GROUP ASSIGNMENT DOES NOT APPEAR TO INCREASE OVERALL ADVERSE EVENTS DESPITE THE NEW TECHNICAL STRATEGIES. [FIGURE 1.] RETROGRADE AND ANTEGRADE KISSING WIRE TECHNIQUE A FIELDER WIRE (ASAHI-INTEC) WAS ADVANCED CAREFULLY FROM THE SEPTAL, THROUGH THE RIGHT POSTERIOR DESCENDING ARTERY, AND INTO THE DISTAL RIGHT CORONARY ARTERY (C). [FIGURE 2.] PRIMARY RETROGRADE WIRE CROSSING A FIELDER FINE CONTROL WIRE (ASAHI-INTEC) WAS ADVANCED THROUGH THE SEPTAL COLLATERAL AND ENGAGED IN THE DISTAL CHRONIC TOTAL OCCLUSION CAP (C). [FIGURE 3.] CART TECHNIQUE A 0.014-INCH FIELDER FINE CONTROL WIRE (ASAHI-INTEC) WAS PLACED FROM THE LEFT ANTERIOR DESCENDING ARTERY TO RIGHT CORONARY ARTERY POSTERIOR DESCENDING ARTERY INTO AN ACUTE MARGINAL BRANCH USING MICROCATHETER SUPPORT, SEPTAL DILATION PERFORMED WITH A 1.5-MM BALLOON AT 1 ATM, AND A 2.5 ?~15 MM VOYAGER (ABBOTT VASCULAR) BALLOON PLACED IN THE MID/DISTAL RIGHT CORONARY ARTERY. (B) AFTER INABILITY TO PENETRATE THE DISTAL CAP RETROGRADE WITH MULTIPLE WIRES, A CONFIANZA PRO 9 G WIRE (ASAHI-INTEC) WAS DELIVERED RETROGRADE INTO THE PROXIMAL RIGHT CORONARY ARTERY SUBINTIMAL SPACE, AS DETERMINED BY INTRAVASCULAR ULTRASOUND (YELLOW ARROW). AN ANTEGRADE CONFIANZA PRO 12 G WIRE (ASAHI-INTEC) WAS INTRODUCED INTO THE PROXIMAL CHRONIC TOTAL OCCLUSION USING INTRAVASCULAR ULTRASOUND GUIDANCE. FIELDER FC: MFR REPORT #: 3003775027-2023-00102 MIRACLEBROS 3: MFR REPORT #: 3003775027-2023-00103 MIRACLEBROS 6: MFR REPORT #: 3003775027-2023-00104 MIRACLEBROS 12: MFR REPORT #: 3003775027-2023-00105 CONFIANZA PRO 9: MFR REPORT #: 3003775027-2023-00106 CONFIANZA PRO 12: MFR REPORT #: 3003775027-2023-00107.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1433766 | FIELDER | PTCA GUIDE WIRE | DQX | ASAHI INTECC CO., LTD. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening |