UNK_QDOT MICRO
Report
- Report Number
- 2029046-2025-00964
- Event Type
- Malfunction
- Date Received
- March 29, 2025
- Report Date
- March 29, 2025
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- OAE
- PMA / PMN Number
- P210027
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 REF. NO:(B)(4).
THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: KEWCHAROEN J, SHAH K, BHARDWAJ R, TURAGAM MK, CONTRACTOR T, MANDAPATI R, LAKKIREDDY D, GARG J. CATHETER-RELATED AND CLINICAL COMPLICATIONS ASSOCIATED WITH QDOT MICROTM ABLATION CATHETER. J CARDIOVASC ELECTROPHYSIOL. 2024 SEP;35(9):1874-1877. DOI: 10.1111/JCE.16363. EPUB 2024 JUL 8. PMID: 38978283. THE FIRST ARTICLE REPORTED IN THIS COMPLAINT IS RELATED TO ANOTHER ARTICLE THAT ALSO REPORTED CATHETER RELATED AND CLINICAL COMPLICATIONS ASSOCIATED WITH QDOT ABLATION CATHETER. THE DATES OVERLAP (THE FIRST ARTICLE DID A SEARCH FROM INCEPTION OF THE CATHETER-OCTOBER 2023, WHILE THE DATES FROM THE SECOND ARTICLE SPAN FROM NOV 2022 ¿ APRIL 2024). THEREFORE, TO CONSERVATIVELY REPORT THE DEVICE ISSUES AND ADVERSE EVENTS THAT WERE NOT CAPTURED IN THE ORIGINAL ARTICLE, THE FOLLOWING ADVERSE EVENTS ARE TO BE REPORTED: ADVERSE EVENTS: - 35 PERICARDIAL EFFUSIONS REQUIRING PERICARDIOCENTESIS OR SURGERY - 4 PATIENT HAD A STROKE, NO REPORTED INTERVENTION - 6 PATIENTS HAD PERICARDITIS, NO REPORTED INTERVENTION - 3 ESOPHAGEAL FISTULAS - 6 PHRENIC NERVE PALSY, ALL PERSISTENT AT THE TIME OF THE EVENT REPORTING, NONE REQUIRED INTERVENTION - 1 PATIENTS WITH VENTRICULAR FIBRILLATION - 4 PATIENTS HAD SIGNIFICANT AV BLOCK THAT REQUIRED PERMANENT PACEMAKERS - 3 PATIENTS WITH PULMONARY VEIN STENOSIS NONSERIOUS EVENTS: - 2 PERICARDIAL EFFUSIONS THAT DID NOT REQUIRE INTERVENTION DEATHS: - 9 DEATHS TOTAL - 4 OTHER "ESOPHAGEAL COMPLICATIONS" (ESOPHAGEAL FISTULAS) - 4 RELATED TO CARDIAC ARREST - 1 VENTRICULAR FIBRILLATION / CARDIAC ARREST REPORTABLE MALFUNCTIONS: - 11 PATIENTS HAD CATHETER THROMBOSIS, NO REPORTED INTERVENTION. - 16 IRRIGATION ISSUE MALFUNCTIONS: - 18 PATIENTS HAD CHAR FORMATION FOR WHICH 50% OF THE EVENTS REPORTED USE OF THE VHPSD STRATEGY. - 148 PHYSICAL CATHETER DAMAGE - 106 COMMUNICATION ISSUE / DISPLAY ISSUE - 12 SIGNAL ISSUE / ARTIFACT - 3 INACCURATE TEMPERATURE THIS REPORT IS BEING SENT TO ADDRESS THE "REPORTABLE MALFUNCTIONS" SECTION, FEATURING 11 PATIENTS WITH CATHETER THROMBOSIS AND 16 IRRIGATION ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692853 | UNK_QDOT MICRO | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION | OAE | BIOSENSE WEBSTER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |