THERMOCOOL SMARTTOUCH

Report

Report Number: 2029046-2022-01572
Event Type: Death
Date Received: July 11, 2022
Date of Event: November 28, 2007
Report Date: July 10, 2022
Manufacturer: BIOSENSE WEBSTER INC
Product Code: LPB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ANTZ M, BERODT K, BÄNSCH D, ERNST S, CHUN KJ, SATOMI K, SCHMIDT B, BOCZOR S, OUYANG F, KUCK KH. CATHETER-ABLATION OF VENTRICULAR TACHYCARDIA IN PATIENTS WITH CORONARY ARTERY DISEASE: INFLUENCE OF THE ENDOCARDIAL SUBSTRATE SIZE ON CLINICAL OUTCOME. CLIN RES CARDIOL. 2008 FEB;97(2):110-7. DOI: 10.1007/S00392-007-0596-7. EPUB 2007 NOV 28. PMID: 18046530. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

Description of Event or Problem · 0

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ANTZ M, BERODT K, BÄNSCH D, ERNST S, CHUN KJ, SATOMI K, SCHMIDT B, BOCZOR S, OUYANG F, KUCK KH. CATHETER-ABLATION OF VENTRICULAR TACHYCARDIA IN PATIENTS WITH CORONARY ARTERY DISEASE: INFLUENCE OF THE ENDOCARDIAL SUBSTRATE SIZE ON CLINICAL OUTCOME. CLIN RES CARDIOL. 2008 FEB;97(2):110-7. DOI: 10.1007/S00392-007-0596-7. EPUB 2007 NOV 28. PMID: 18046530. OBJECTIVE/METHODS/STUDY DATA: ABLATION OF SYMPTOMATIC VENTRICULAR TACHYCARDIA (VT) IN PATIENTS WITH CORONARY ARTERY DISEASE IS FREQUENTLY PERFORMED USING THE THREE DIMENSIONAL MAPPING SYSTEM CARTO. IN THE AMPLITUDE MAP, BIPOLAR POTENTIALS OF <1.5 MV ARE CONSIDERED ABNORMAL AND REPRESENT DAMAGED MYOCARDIUM DUE TO PREVIOUS INFARCTION. THIS PATHOLOGICAL ELECTRICAL AREA CAN BE ARRHYTHMOGENIC, SERVING AS THE SUBSTRATE FOR REENTRANT VT. THE PURPOSE OF THIS STUDY WAS TO CORRELATE THE SIZE OF THE ENDOCARDIAL SUBSTRATE WITH THE SUCCESS OF VT CATHETER ABLATION. INCLUDED IN THIS RETROSPECTIVE ANALYSIS WERE 69 CONSECUTIVE PATIENTS WITH CORONARY ARTERY DISEASE WHO UNDERWENT ABLATION FOR SYMPTOMATIC CLINICAL VT USING CARTO. THE VOLTAGE MAPS WERE ANALYZED AND THE AREA WITH ABNORMAL BIPOLAR ELECTROGRAMS (<1.5 MV) WAS DETERMINED USING GEOMETRIC APPROXIMATION MODELS. THE AREA OF ABNORMAL ELECTROGRAMS WAS DIVIDED INTO THREE SIZES: SMALL (£15 CM2; 11 PATIENTS), MEDIUM (16¿99 CM2; 50 PATIENTS), AND LARGE (¿100 CM2; 8 PATIENTS). PATIENT CHARACTERISTICS WERE NOT DIFFERENT BETWEEN THE THREE SUBSTRATE GROUPS IN REGARD TO AGE, TACHYCARDIA CYCLE LENGTH, OR NUMBER OF RADIOFREQUENCY APPLICATIONS, HOWEVER DIFFERED SIGNIFICANTLY BETWEEN THE SMALL, MEDIUM AND LARGE GROUP IN REGARD TO LEFT VENTRICULAR EJECTION FRACTION (44 ± 12% VS. 32 ± 9% VS. 21 ± 7%, RESPECTIVELY; P = 0.001). OVERALL, THERE WAS A SIGNIFICANT CORRELATION BETWEEN MYOCARDIAL INFARCTION LOCATIONS AND ENDOCARDIAL SUBSTRATE SIZES (P = 0.031), SUCH THAT 73% OF SMALL SUBSTRATES WERE FOUND AFTER INFERIOR MYOCARDIAL INFARCTIONS, AND 100% OF LARGE SUBSTRATES AFTER ANTERIOR AND MULTIPLE MYOCARDIAL INFARCTIONS (P = 0.003). AFTER ABLATION, INDUCIBILITY OF VENTRICULAR ARRHYTHMIAS WAS MORE RARE IN PATIENTS WITH SMALL SUBSTRATES COMPARED TO PATIENTS WITH MEDIUM OR LARGE SUBSTRATES (SMALL SUBSTRATES: 9%, MEDIUM AND LARGE SUBSTRATES: 43%, P = 0.043). ALTHOUGH DURING FOLLOW-UP OF 25 ± 17 MONTHS (1 DAY TO 72 MONTHS) THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN ENDOCARDIAL SUBSTRATE SIZES IN REGARD TO RECURRENCE RATES (SMALL: 27%, MEDIUM: 38%, LARGE: 50%, P = 0.588), PATIENTS WITH A SMALL SUBSTRATE DID NOT HAVE FAST VT OR VENTRICULAR FIBRILLATION (VF), IN CONTRAST TO 30% AND 38% OF PATIENTS WITH MEDIUM AND LARGE SUBSTRATES, RESPECTIVELY. WE CONCLUDE THAT IN PATIENTS WITH CORONARY ARTERY DISEASE A SMALL AREA OF LOW AMPLITUDE BIPOLAR POTENTIALS (£15 CM2) WAS SEEN MORE OFTEN AFTER INFERIOR MYOCARDIAL INFARCTION THAN AFTER ANTERIOR AND MULTIPLE INFARCTIONS. AFTER ABLATION, PATIENTS WITH SMALL SUBSTRATES WERE RARELY INDUCIBLE AND SHOWED A MORE BENIGN COURSE DURING FOLLOW-UP (TREND TOWARDS FEWER ARRHYTHMIA RECURRENCES AND NO FAST VT OR VF). AS A RESULT SMALLER ARRHYTHMOGENIC SUBSTRATES APPEAR TO BE BETTER AMENABLE TO CATHETER ABLATION THAN LARGER SUBSTRATES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: IRRIGATED 3.5 MM TIP; NAVISTAR THERMOCOOL, BIOSENSE-WEBSTER OR 4 MM TIP; NAVISTAR, BIOSENSE-WEBSTER LTD). OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO; 6F PARAHIS CATHETER (BIOSENSE-WEBSTER, INC). NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: SR0, ST. JUDE MEDICAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: EARLY PERIPROCEDURAL DEATH OCCURRED IN 1 PATIENT THE NIGHT AFTER THE PROCEDURE DUE TO ELECTRO-MECHANICAL DISSOCIATION AFTER CARDIAC TAMPONADE. THERE WAS NO MENTION OF INTERVENTIONS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1014248	THERMOCOOL SMARTTOUCH	CARDIAC ABLATION PERCUTANEOUS CATHETER	LPB	BIOSENSE WEBSTER INC

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Life Threatening\| D	6F PARAHIS CATHETER (BIOSENSE-WEBSTER, INC)\| SR0, ST. JUDE MEDICAL\| UNK_CARTO 3