MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Insufficient Cooling (1130); Temperature Problem (3022); Patient Device Interaction Problem (4001)

Patient Problem Ventricular Fibrillation (2130)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient ((b)(6)) born (b)(6) underwent an atrial flutter right (r-afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered ventricular fibrillation (vf).After some mapping, the ablation catheter temperature readings went up to 50 degrees celsius.The catheter was removed from the body and no char was noted.Caller states there were no impedance spikes noted.After reinserting the catheter, temperatures were not displayed, and 60 cycle noise was displayed on the bs signals.The ablation cable was replaced, and this resolved the temperature reading issue, but not the noise issue.Isoproterenol was started, and as the catheter was removed again, and the patient went into ventricular fibrillation (vf).The patient was defibrillated once with successful termination of the vf.Again, no char was noted on the catheter.No errors were ever displayed on the carto 3 system.The catheter was replaced, and the noise issue was resolved.The patient was stable, and the procedure was continued and completed.The physician was not delivering energy when it was noted that the temp was high.Clinical noticed high temp reading on smartablate remote prior to any additional lesion given by physician.Smartablate was in the stsf default setting with time at 180 physician never delivered any lesions longer than 20 seconds with variable power between 30-40 watts.This adverse event was discovered during use of biosense webster products: it was noted that stsf read high temp shortly after rf was delivered by physician.Troubleshooting of high temp was completed by replacing cable which did not resolve issue of bs noise resolved issue if high temp reading.As catheter was being withdrawn by md to exchange for replacement catheter it was noted patient was in vf.The physician¿s opinion on the cause of this adverse event: the doctor reports that perhaps a combination of isuprel and catheter manipulation and removed could have caused event bwi product malfunction -stsf, procedure -typical flutter and patient condition -stable.Medical or surgical intervention: only external defibrillation times 1.The patient outcome of the adverse event: fully recovered.It is unknown if the patient required extended hospitalization because of the adverse event.The temperature issues are not mdr-reportable.However, the event is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

On 23-sep-2021, the bwi product analysis lab received the device for evaluation.The 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 reference number: (b)(4).

Manufacturer Narrative

On 25-mar-2022, the product investigation was completed.It was reported that a female patient (102kg) born (b)(6) 1967 underwent an atrial flutter right (r-afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered ventricular fibrillation (vf).After some mapping, the ablation catheter temperature readings went up to 50 degrees celsius.The catheter was removed from the body and no char was noted.Caller states there were no impedance spikes noted.After reinserting the catheter, temperatures were not displayed, and 60 cycle noise was displayed on the bs signals.The ablation cable was replaced, and this resolved the temperature reading issue, but not the noise issue.Isoproterenol was started, and as the catheter was removed again, and the patient went into ventricular fibrillation (vf).The patient was defibrillated once with successful termination of the vf.Again, no char was noted on the catheter.No errors were ever displayed on the carto 3 system.The catheter was replaced, and the noise issue was resolved.The patient was stable, and the procedure was continued and completed.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the thmcl smtch sf catheter.A product investigation was performed on the returned device and electrical issues were observed.Further investigation revealed water leakage from the handle, creating corrosion on the internal electrical components.Therefore, a manufacturing investigation was performed to investigate the leakage and it was determined that the irrigation tube was found incorrectly assembly.An awareness training was performed on the production associates to reduce this issue.A manufacturing record evaluation was performed for the finished device 30560187m number, and no internal actions related to the complaint were found during the review.The root cause of the adverse event remains unknown.With the available information, the investigation results cannot be related to the adverse reported by the customer in addition, the physician¿s opinion on the cause of this adverse event: the doctor reports that perhaps a combination of isuprel and catheter manipulation and removed could have caused the event.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12493832
• MDR Text Key: 272118581
• Report Number: 2029046-2021-01589
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30560187M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 09/23/2021; 03/25/2022
• Supplement Dates FDA Received: 10/04/2021; 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SMARTABLATE GENERATOR; STSF CATHETER CABLE; CARTO 3 SYSTEM; SMARTABLATE GENERATOR; STSF CATHETER CABLE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 102 KG