UNK_QDOT MICRO

Report

Report Number: 2029046-2023-01893
Event Type: Injury
Date Received: August 25, 2023
Date of Event: December 1, 2022
Report Date: August 25, 2023
Manufacturer: BIOSENSE WEBSTER INC
Product Code: OAE
PMA / PMN Number: P210027
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 MUELLER J, NENTWICH K, ENE E, BERKOVITZ A, SONNE K, CHAKAROV I, BARTH S, WAECHTER C, BEHNES M, AKIN I, HALBFASS P, DENEKE T. RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION-50 W OR 90 W. J CARDIOVASC ELECTROPHYSIOL. 2022 DEC;33(12):2504-2513. DOI: 10.1111/JCE.15681. EPUB 2022 OCT 8. PMID: 36124396. 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. THIS REPORT IS BEING SUBMITTED LATE DUE TO A RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE QDOT MICRO PRODUCTS. BIOSENSE WEBSTER¿S INVESTIGATION DETERMINED THAT UPON APPROVAL OF QDOT IN THE UNITED STATES ON (B)(6), 2022, THE ELECTRONIC COMPLAINTS SYSTEM WAS NOT UPDATED AND THEREFORE MEDICAL DEVICE REPORTS WERE NOT SUBMITTED IN A TIMELY MANNER. THROUGH BIOSENSE WEBSTER¿S INVESTIGATION IT WAS DETERMINED THAT THIS WAS AN ISOLATED CASE. AN INTERNAL ACTION WAS OPENED TO ADDRESS THIS ISSUE. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER PC-001294643 HAS TWO REPORTS: (1) MFR # 2029046-2023-00399 FOR PRODUCT CODE UNK UNK_SMART TOUCH BIDIRECTIONAL SF.

Description of Event or Problem · 0

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED MUELLER J, NENTWICH K, ENE E, BERKOVITZ A, SONNE K, CHAKAROV I, BARTH S, WAECHTER C, BEHNES M, AKIN I, HALBFASS P, DENEKE T. RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION-50 W OR 90 W. J CARDIOVASC ELECTROPHYSIOL. 2022 DEC;33(12):2504-2513. DOI: 10.1111/JCE.15681. EPUB 2022 OCT 8. PMID: 36124396. OBJECTIVE AND METHODS: BACKGROUND: THIS STUDY SOUGHT TO EVALUATE THE SHORT AND MIDTERM EFFICACY AND SAFETY OF THE NOVEL VERY HIGH POWER VERY SHORT DURATION (VHPVSD) 90 W APPROACH COMPARED TO HPSD 50 W FOR ATRIAL FIBRILLATION (AF) ABLATION AS WELL AS RECONNECTION PATTERNS OF 90 W ABLATIONS. METHODS AND RESULTS: CONSECUTIVE PATIENTS UNDERGOING FIRST AF ABLATION WITH VHPVSD (90 W; PREDEFINED ABLATION TIME OF 3 S FOR POSTERIOR WALL ABLATION AND 4 S FOR ANTERIOR WALL ABLATION) WERE COMPARED TO PATIENTS USING HPSD (50 W; ABLATION INDEX-GUIDED; AI 350 FOR POSTERIOR WALL ABLATION, AI 450 FOR ANTERIOR WALL ABLATION) RETROSPECTIVELY. A TOTAL OF 84 PATIENTS (67.1 ± 9.8 YEARS; 58% MALE; 47% PAROXYSMAL AF) WERE INCLUDED (42 WITH 90 W, 42 WITH 50 W) OUT OF A PROPENSITY SCORE-MATCHED COHORT. 90 W ABLATIONS REVEALED SHORTER ABLATION TIMES (10.5 ± 6.7 MIN VS. 17.4 ± 9.9 MIN; P = .001). NO MAJOR COMPLICATION OCCURRED. 90 W ABLATIONS REVEALED LOWER FIRST PASS PVI RATES (40% VS. 62%; P = .049) AND HIGHER AF RECURRENCES DURING BLANKING PERIOD (38% VS. 12%; P = .007). AFTER 12 MONTHS, BOTH ABLATION APPROACHES REVEALED COMPARABLE MIDTERM OUTCOMES (62% VS. 70%; LOG-RANK P = .452). IN A MULTIVARIABLE COX REGRESSION MODEL, PERSISTENT AF (HAZARD RATIO [HR]: 1.442, 95% CONFIDENCE INTERVAL [CI]: 1.035-2.010, P = .031) AND INCREASED PROCEDURAL DURATION (HR: 1.011, 95% CI: 1.005-1.017, P = .001) WERE IDENTIFIED AS INDEPENDENT PREDICTORS OF AF RECURRENCE DURING FOLLOW-UP. CARDIOVERSION WAS PERFORMED WHEN AF PERSISTED DURING VOLTAGE MAPPING. CONCLUSIONS: AF ABLATION USING 90 W VHPVSD REVEALS A SIMILAR SAFETY PROFILE COMPARED TO 50 W ABLATION WITH SHORTER ABLATION TIMES. HOWEVER, VHPVSD ABLATION WAS ASSOCIATED WITH LOWER RATES OF FIRST-PASS ISOLATIONS AND INCREASED AF RECURRENCES DURING THE BLANKING PERIOD. AFTER 12 MONTHS, 90 W REVEALED COMPARABLE EFFICACY RESULTS TO 50 W ABLATIONS IN A NONRANDOMIZED, PROPENSITY-MATCHED COMPARISON. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE WEBSTER DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMART-TOUCH STSF USED IN HPSD GROUP AT 50W. QDOT MICROUSED FOR PVI GROUP AT 90W. LASSO USED IN ALL STUDY GROUPS. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: RF GENERATOR (NGEN). SMARTBLATE GENERATOR. QMODE PLUS. CARTO 3. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: AGILIS SHEATH (ABBOTT). ADVERSE EVENT(S) AND INTERVENTIONS: IN THE THERMOCOOL STSF/LASSO 50W GROUP: 14 PERICARDIAL EFFUSIONS- NO TREATMENT PROVIDED. 6 IMPLANTED PACEMAKERS TO TREAT PERSISTENT AF DURING VOLTAGE MAPPING. 35 ESOPHAGEAL LESIONS- NO TREATMENT SPECIFIED. IN THE QDOT/LASSO 90 W GROUP: 1 PERICARDIAL EFFUSION- NO TREATMENT PROVIDED. 1 IMPLANTED PACEMAKER TO TREAT PERSISTENT AF DURING VOLTAGE MAPPING. 1 ESOPHAGEAL LESION- NO TREATMENT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1386889	UNK_QDOT MICRO	CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION	OAE	BIOSENSE WEBSTER INC

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Life Threatening\| R	AGILIS SHEATH (ABBOTT).\| CARTO 3.\| QMODE PLUS.\| RF GENERATOR (NGEN).\| SMARTBLATE GENERATOR.