BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATER

    MDR report key: 8681426 · Received June 9, 2019

    Report

    Report Number
    3003775027-2019-00095
    Event Type
    Injury
    Date Received
    June 9, 2019
    Date of Event
    May 2, 2019
    Report Date
    May 22, 2019
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON AUGUST 7, 2019, ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOT NUMBER WAS NOT CONFIRMED BUT COULD BE 190225A01A. CATALOG #: AGH146000 LOT #: 190225A01A EXPIRATION DATE: 01/31/2022 UNIQUE IDENTIFIER (UDI) #: (B)(4). PMA/510(K): K022762 DEVICE MANUFACTURE DATE: 03/07/2019 MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749 LOT HISTORY RECORDS REVIEW WAS PERFORMED FOR THIS SUSPICIOUS LOT. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS SUSPICIOUS LOT.

    Additional Manufacturer Narrative · 0

    ASAHI INTECC HAS DETERMINED THAT THE DATE RECORDED IN BLOCK B4 "DATE OF THIS REPORT" WAS ERRONEOUSLY REPORTED AS THE DATE THE REPORT WAS SUBMITTED RATHER THAN THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY. CORRECTIVE ACTION HAS BEEN TAKEN TO CLARIFY WHICH DATE SHOULD BE PROVIDED IN THE REPORT. THIS SUPPLEMENTAL REPORT IS INTENDED ONLY TO CORRECT THE DATE PROVIDED IN BLOCK B4 TO REFLECT THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE DETERMINED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. SINGLE REPORTER EXEMPTION E2015028. THE IMPORTER REPORT NUMBER USED FOR THIS REPORT WAS GENERATED FROM THE IMPORTER REGISTRATION NUMBER, CURRENT YEAR, AND SEQUENTIAL NUMBER THAT MATCH THE MANUFACTURER REPORT NUMBER. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED. INVESTIGATION OF PRODUCTION RECORDS AND ADVERSE EVENTS DATA COULD NOT BE PERFORMED BECAUSE LOT INFORMATION WAS UNAVAILABLE. ALTHOUGH THE DEVICE INVESTIGATION AND LOT HISTORY REVIEW COULD NOT BE CONDUCTED, ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA; THEREFORE, IT WAS CONCLUDED THERE WAS NO INDICATION OF PRODUCT DEFICIENCY. IT WAS INFERRED THAT ANATOMICAL CONDITION AND/OR WIRE MANIPULATION TECHNIQUE MOST LIKELY CONTRIBUTED TO THE REPORTED PERFORATION. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] DO NOT PUSH THE GUIDE WIRE MORE THAN NECESSARY TO ADVANCE THE TIP THROUGH THE NARROWED PART OF THE VESSEL. (FOR EXAMPLE, DO NOT PUSH THE GUIDE WIRE WHEN THE DISTAL TIP OF THE GUIDE WIRE IS BENT BY THE FORCE OF MANIPULATION.) AFTER CROSSING THE TARGETED AREA, DO NOT ROUGHLY TWIST, PUSH OR PULL THE GUIDE WIRE. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BE DAMAGED OR BREAK APART, WHICH MAY INJURE THE BLOOD VESSEL OR LEAVE FRAGMENTS INSIDE THE VESSEL; [WARNINGS] 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; AND, [MALFUNCTION AND ADVERSE EFFECTS] DAMAGE TO A VESSEL, INCLUDING POSSIBLE VESSEL PERFORATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL ASAHI DEVICES WERE USED IN A PCI TO TREAT A MODERATE TO SEVERE STENOSIS IN THE OSTIUM OF THE LEFT MAIN (LMT) AND A LONG, SEVERELY CALCIFIED CTO IN THE RIGHT CORONARY ARTERY (RCA). A 4X8MM STENT WAS DEPLOYED IN THE LMT STENOSIS. TO TREAT THE CTO IN THE RCA, RETROGRADE APPROACH WAS TAKEN AND 4 DRUG ELUTING STENTS WERE DEPLOYED AROUND THE ATRIOVENTRICULAR (AV) GROOVE THROUGH THE POSTERIOR DESCENDING ARTERY (PDA). ANGIOGRAM SHOWED EXTRAVASATION AT THE MID RCA. IT WAS SEALED WITH TWO COVERED STENTS. THE PATIENT HAD BEEN STABLE THROUGHOUT THE PROCEDURE. OBTAINED CASE NOTES OF THE PROCEDURE WAS WRITTEN AS FOLLOWS: "[AFTER LTM TREATMENT WAS COMPLETED] NEXT, WE TURNED OUR ATTENTION TO THE RIGHT CORONARY ARTERY. THROUGH THE 8 FRENCH AL 0.75 GUIDE CATHETER, WE PASSED A SHOT CORSAIR CATHETER WITH GLADIUS WIRE. WE WIRE DOWN THROUGH THE PROXIMAL CAP WITH THIS AND WE WERE ABLE TO MAKE OUR WAY DOWN THE ARCHITECTURE OF THE RIGHT CORONARY ARTERY THOUGH THIS DID APPEAR TO BE GOING AROUND THE HEAVY CALCIUM. HOWEVER, THE WIRE CONTINUES TO MOVE FAIRLY FREELY AND WE EVENTUALLY WERE ABLE TO WIRE INTO THE DISTAL ARCHITECTURE OF THE VESSEL. RETROGRADE INJECTION CONFIRMED THAT WE WERE IN A SMALL BRANCH. WE SPUN THE CORSAIR CATHETER DOWN THE VESSEL BUT THIS WOULD NOT GO THROUGH THE STENOSIS AND SO WE EVENTUALLY SWITCHED OUT FOR A TURNPIKE LP CATHETER. AN 8 FRENCH TRAPLINER WAS ADDED FOR ADDITIONAL SUPPORT. WE ARE ABLE TO SPIN THE TURNPIKE LP CATHETER DOWN THROUGH THE DISTAL LESION INTO THE SMALL BRANCH AND THE GLADIUS WIRE WAS REMOVED AND REPLACED WITH A PROWATER WIRE. NEXT, WE PASSED A 2.0 X 40 MM APEX BALLOON AND DILATED OPEN THE AV GROOVE RIGHT CORONARY ARTERY WITH MULTIPLE BALLOON INFLATIONS UP TO 18 ATM. WE DID DO A TEST INJECTION WHICH SHOWED FLOW INTO THE SMALL BRANCH WE ORIENTED BUT SLOW FLOW INTO THE 2 MAIN BRANCHES THAT WE ARE TRYING TO GET OPEN. WE THEN PASSED A TWIN PASS CATHETER DOWN OVER THE WIRE TO GET A SECOND WIRE INTO THE DISTAL VESSEL. TUBAL WIRES INCLUDING A GLADIUS WIRE AND PROWATER WIRE WERE USED TO TRY TO REENTER 1 OF THE MAIN BRANCHES BUT WE WERE UNSUCCESSFUL IN GETTING INTO EITHER OF THE MAIN BRANCHES. AFTER CONSIDERABLE EFFORT, WE DECIDED TO GO RETROGRADE TO GET INTO THE PDA. A PROWATER WIRE WAS PASSED INTO THE LAD AND DOWN THE SEPTAL PERFORATOR. WE THEN PASSED THE 150 TURNPIKE LP CATHETER INTO THIS SEPTAL. THIS WIRE WAS THEN REMOVED AND REPLACED WITH A SION WIRE WHICH WE ARE ABLE TO WIRE WITH SOME DIFFICULTY THROUGH THE ARCHITECTURE AND INTO THE PDA. WE THEN SPUN THE TURNPIKE LP CATHETER DOWN THROUGH THE SEPTAL PERFORATOR AND INTO THE PDA. WE THEN SPUN THE TURNPIKE LP CATHETER DOWN THROUGH THE SEPTAL PERFORATOR AND INTO THE PDA. WE WERE ABLE TO DIRECT THE GLADIUS WIRE BACK UP THE AV GROOVE BUT IT WAS FAIRLY CLEAR THAT WE ARE IN THE SUBINTIMAL SPACE. THIS WIRE WAS EVENTUALLY REMOVED AND WE TOOK A FIELDER XT WIRE WHICH WERE THEN ABLE TO KNUCKLE RETROGRADE. WE THEN TOOK A 3.5 X 40 MM APEX BALLOON AND DID SEVERAL BALLOON INFLATIONS IN THE AV GROOVE RIGHT CORONARY ARTERY TO JOIN OUR SPACES THOUGH OUR ANTEGRADE WIRE APPEARED TO BE IN THE TRUE LUMEN AND A RETROGRADE ROUTE WIRE IN THE SUBINTIMAL SPACE. WE WERE ABLE TO INCH WORM OUR GUIDE EXTENDER DOWN ABOUT HALFWAY INTO THE MID RIGHT CORONARY ARTERY BUT COULD NOT GET THIS ANY FURTHER. WE TRIED TO REENTER INTO THE GUIDE EXTENDER WITH MULTIPLE WIRES INCLUDING A GLADIUS WIRE, A CONFIANZA PRO 12 WIRE, AND A GAIA THIRD WIRE WITHOUT SUCCESS. WE EVENTUALLY PASSED A 4.0 X 15 MM WOLVERINE CUTTING BALLOON TO TRY TO HELP JOIN THE 2 SPACES AND THIS WAS INFLATED TO 10 ATM. AFTER THIS, WE WERE THEN ABLE TO WIRE RETROGRADE INTO THE ANTEGRADE GUIDE EXTENDER. WITH THIS IN POSITION, WE SPUN THE TURNPIKE BACK THROUGH INTO THE ANTEGRADE GUIDE AND THE GAIA WIRE WAS REMOVED AND REPLACED WITH OUR 350 WIRE. WE THEN PASSED THIS WIRE UP TO THE AORTIC ARCH AND THEN PASSED A BARE CORSAIR CATHETER TO TIP IN ON THE WIRE. ONCE THIS WAS ON THE WIRE, WE SPUN THE CORSAIR CATHETER THROUGH THE CTO INTO THE PDA AS WE MOVED TO THE RETROGRADE TURNPIKE LP BACKWARDS INTO THE SEPTUM. ONCE WE ARE IN ADEQUATE POSITION THE EXTERNALIZATION WIRE WAS REMOVED. WE THEN PASSED A PROWATER WIRE DOWN THE CORSAIR CATHETER INTO THE PDA AND THE CORSAIR CATHETER WAS THEN REMOVED. NEXT, THE TWIN PASS CATHETER WAS PASSED OVER THE WIRE AND WE USED SEVERAL MORE WIRES TO TRY TO GET OUT TO THE POSTERIOR LATERAL BRANCH BUT DESPITE CONSIDERABLE EFFORTS HAD DIFFICULTY GETTING OUT INTO THIS BRANCH. THIS POINT, WE DECIDED TO BALLOON AND STENT INTO THE PDA. WE PREDILATED THE LESION INTO THE PDA WITH A 2.0 X 40 MM APEX BALLOON WITH BALLOON INFLATION TO 12 ATM. WE THEN TRIED TO DELIVER A STENT BUT THIS WOULD NOT GO THROUGH THE MID TO DISTAL VESSEL. A 2.5 X 30 MM TREK BALLOON WAS USED TO DILATE OPEN THIS AREA WITH A BALLOON INFLATION TO 16 ATM. WE AGAIN TRIED TO PASS THE STENT WITHOUT SUCCESS. WE THEN PASSED THE CORSAIR CATHETER OVER THE WIRE AND THE WIRE WAS REMOVED AND REPLACED WITH A WIGGLE WIRE. WITH THIS, WE WERE ABLE TO DELIVER A 3.0 X 38 MM XIENCE SIERRA STENT TO THE DISTAL VESSEL AND THIS WAS POSITIONED JUST AT THE PROXIMAL PDA. THIS WAS THEN DEPLOYED AT 12 ATM. NEXT, A 4.0 X 38 MM XIENCE SIERRA STENT WAS THEN DELIVERED TO THE DISTAL AV GROOVE RCA AND DEPLOYED AT 14 ATM. A SECOND 4.0 X 38 MM XIENCE SIERRA STENT WHICH ALSO WAS DEPLOYED AT 14 ATM. FOLLOW-UP ANGIOGRAPHY REVEALED RESTORATION OF ANTEGRADE FLOW INTO THE PDA. THERE WAS A HIGH-GRADE STENOSIS IN THE PDA JUST DISTAL TO THE STENTED SEGMENT. IN ADDITION, IN THE MID AV GROOVE RIGHT CORONARY ARTERY THERE WAS SOME DYE EXTRAVASATION OUTSIDE OF THE ARCHITECTURE OF THE VESSEL THOUGH THIS DID NOT APPEAR TO BE FREE-FLOWING. HE WAS HEMODYNAMICALLY STABLE THROUGHOUT THIS TIME AS WELL. WE CALLED FOR AN ECHOCARDIOGRAM WHICH EVENTUALLY ARRIVED AND SHOWED NO EVIDENCE OF PERICARDIAL FLUID. WE THEN STENTED THE PDA. WE PREDILATED THE PDA WITH A 2.0 X 20 MM TREK BALLOON INFLATED WITH SEVERAL BALLOON INFLATIONS TO 16 ATM. A 2.5 X 23 MM XIENCE SIERRA STENT WAS THEN POSITIONED INTO THE PDA AND DEPLOYED AT 10 ATM. THE OVERLAP WAS POSTDILATED TO 18 ATM. THEN POSTDILATED THE AV GROOVE RIGHT CORONARY ARTERY WITH A 4.0 X 15 MM NC QUANTUM APEX BALLOON WITH MULTIPLE BALLOON INFLATIONS UP TO 18 ATM. FOLLOW-UP ANGIOGRAPHY SHOWED A REASONABLE STENT RESULT THOUGH THE MID RCA DID HAVE THE AREA WHERE THERE IS STILL SOME BORDERLINE EXTRAVASATION. THIS WAS REVIEWED WITH COLLEAGUES AND WE DECIDED TO PLACE COVERED STENTS. WE SUBSEQUENTLY PLACED TWO 4.0 X 19 MM GRAFTMASTER CORONARY COVERED STENTS OVER THIS AREA WHICH MARKEDLY DIMINISHED ANY FLOW INTO THIS AREA. HE REMAINED HEMODYNAMICALLY STABLE. AFTER THE GEAR WAS REMOVED, HE WAS GIVEN PROTAMINE AND TRANSFERRED TO THE ICU IN STABLE CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474861 ASAHI PROWATER PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention