OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
Report
- Report Number
- 2029046-2024-03509
- Event Type
- Malfunction
- Date Received
- October 30, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DRF
- UDI-DI
- 10846835025828
- PMA / PMN Number
- K230253
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
ON 26-DEC-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IT WAS SNAGGED TO THE RV CATHETER. DURING A VT PROCEDURE, THE RIGHT VENTRICLE WAS MAPPED WITH THE OPTRELL MAPPING CATHETER. AT THE SAME TIME, THERE WAS AN RV CATHETER (4 POLES) IN THE RIGHT VENTRICLE FOR STIMULATION. AFTER, THE PHYSICIAN WANTED TO MAP THE LEFT VENTRICLE AND THEREFORE, PERFORM A TRANSSEPTAL PUNCTURE. HE PULLED BACK THE OPTRELL CATHETER FROM THE RIGHT VENTRICLE TO THE SITE OF THE GROIN PUNCTURE AND NOTICED NOTHING UNUSUAL. AS HE WANTS TO PULL THE CATHETER OUT OF THE PATIENT TROUGH THE SHEATH, HE NOTICES RESISTANCE. HE NOTICED, THAT THE OPTRELL CATHETER AND THE RV CATHETER WERE SNAGGED. THERE WAS NO PATIENT CONSEQUENCE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION AND DIMENSIONAL INSPECTION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED THAT ONE OF THE ELECTRODES WAS BENT. THE DIMENSIONAL TEST WAS PERFORMED AND THE OUTER DIAMETERS OF THE SHAFT WERE FOUND WITHIN SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ENTRAPMENT ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED DUE TO THE BENT ELECTRODES. THE POTENTIAL CAUSE OF THE BENT ELECTRODE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS COULD BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE OF THE DEVICE CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH IF RESISTANCE IS ENCOUNTERED; DO NOT INTRODUCE THE CATHETER INTO A GUIDING SHEATH WITH THE CATHETER¿S SPINES FOLDED BACK TOWARD THE HANDLE. COLLAPSE THE SPINES TOGETHER USING THE INSERTION TUBE PRIOR TO INSERTION; THE CATHETER IS RECOMMENDED FOR USE WITH AN 8.5 F GUIDING SHEATH BECAUSE THE SPINES MAY BE DAMAGED IF USED WITH A SHEATH THAT IS NOT COMPATIBLE. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. #(B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IT WAS SNAGGED TO THE RV CATHETER. DURING A VT PROCEDURE, THE RIGHT VENTRICLE WAS MAPPED WITH THE OPTRELL MAPPING CATHETER. AT THE SAME TIME, THERE WAS AN RV CATHETER (4 POLES) IN THE RIGHT VENTRICLE FOR STIMULATION. AFTER, THE PHYSICIAN WANTED TO MAP THE LEFT VENTRICLE AND THEREFORE, PERFORM A TRANSSEPTAL PUNCTURE. HE PULLED BACK THE OPTRELL CATHETER FROM THE RIGHT VENTRICLE TO THE SITE OF THE GROIN PUNCTURE AND NOTICED NOTHING UNUSUAL. AS HE WANTS TO PULL THE CATHETER OUT OF THE PATIENT TROUGH THE SHEATH, HE NOTICES RESISTANCE. HE NOTICED, THAT THE OPTRELL CATHETER AND THE RV CATHETER WERE SNAGGED. THERE WAS NO PATIENT CONSEQUENCE. DEVICE EVALUATION DETAILS: A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH'S PROCEDURES. ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, THE TIP OF BOTH CATHETERS WERE OBSERVED INTERTWINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND A ROOT CAUSE IS UNABLE TO BE ASSIGNED BASED ON THE CURRENT EVIDENCE. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT INVESTIGATION WILL BE PERFORMED AND UPDATED ACCORDINGLY, AND ANY ACTION WILL BE TAKEN IF NECESSARY. : H6. INVESTIGATION FINDINGS CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE (C22)¿ USED TO REPRESENT THE PHOTO ANALYSIS RESULTS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IT WAS SNAGGED TO THE RV CATHETER. DURING A VT PROCEDURE, THE RIGHT VENTRICLE WAS MAPPED WITH THE OPTRELL MAPPING CATHETER. AT THE SAME TIME, THERE WAS AN RV CATHETER (4 POLES) IN THE RIGHT VENTRICLE FOR STIMULATION. AFTER, THE PHYSICIAN WANTED TO MAP THE LEFT VENTRICLE AND THEREFORE, PERFORM A TRANSSEPTAL PUNCTURE. HE PULLED BACK THE OPTRELL CATHETER FROM THE RIGHT VENTRICLE TO THE SITE OF THE GROIN PUNCTURE AND NOTICED NOTHING UNUSUAL. AS HE WANTS TO PULL THE CATHETER OUT OF THE PATIENT TROUGH THE SHEATH, HE NOTICES RESISTANCE. HE NOTICED, THAT THE OPTRELL CATHETER AND THE RV CATHETER WERE SNAGGED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO DAMAGE TO THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY. OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY. IT WAS A LITTLE BIT HARDER TO PULL THE CATHETER BACK THROUGH THE SHEATH BECAUSE IT WAS SNAGGED TO THE RV CATHETER, THEREFORE A LITTLE BIT MORE POWER WAS NEEDED TO PULL THE CATHETER OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1964703 | OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | DRF | BIOSENSE WEBSTER INC | 31362292M | 10846835025828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | RV CATHETER |