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); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with three (3) thermocool® smart touch® sf bi-directional navigation catheter and there was loss of ecg signal with no intact signal available.When the physician started the ablation the ecg signals disappeared and impedance value started to change.There was no error on carto system.Fluoro tube wasn't too close to the location pad and it was in ap location.The cable was changed with new one but nothing changed.Finally, the catheter was changed to a new one.There was no patient consequences.On (b)(6) 2022, additional information was received indicating the physician did not have any intact ecg signal available to monitor patient heart rhythm.The signal loss was observed on all ecg (bs + ic) channels.The signal loss was observed on both carto® and recording system.During the signal loss issue the affected catheter was inside the patient¿s body.The impedance value was variable.The impedance cut-off value was not exceeded.The defibrillator was open and near the patient but it was not connected to the patient.The event was initially assessed as not mdr reportable until (b)(6) 2022 when information was received confirming there was no signal available to monitor patient's cardiac rhythm.

Manufacturer Narrative

The product has not returned for analysis, however, a video was provided by the customer.Evaluation is still in progress.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.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has three (3) reports: mfr # 2029046-2022-00914 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).Mfr # 2029046-2022-00916 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with three (3) thermocool® smart touch® sf bi-directional navigation catheter and there was loss of ecg signal with no intact signal available.When the physician started the ablation the ecg signals disappeared and impedance value started to change.There was no error on carto system.Fluoro tube wasn't too close to the location pad and it was in ap location.The cable was changed with new one but nothing changed.Finally, the catheter was changed to a new one.There was no patient consequences.On 5-apr-2022, additional information was received indicating the physician did not have any intact ecg signal available to monitor patient heart rhythm.The signal loss was observed on all ecg (bs + ic) channels.The signal loss was observed on both carto® and recording system.During the signal loss issue the affected catheter was inside the patient¿s body.Device evaluation details: the catheter was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection, generator, and electrical test of the returned catheter.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Nor was there any evidence of char.Generator and ecg testing were performed in accordance with bwi procedures.The catheter passed the temperature, impedance, and electrical test within specification.However, the customer provided a video of the reported problem to aid in the investigation.According to the video provided by the customer, unstable impedance readings were observed on carto 3 screen.Customer reported impedance issue was confirmed based on the video received.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process, all catheters are manufactured, inspected, and released to approved specifications.The instructions for use contain the following recommendations: when rf current is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed.The reported events could not be confirmed during product evaluation since the catheter performed without any issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the catheter that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 18-may-2022, 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).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14250360
• MDR Text Key: 290461369
• Report Number: 2029046-2022-00915
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30616811L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 05/18/2022; 05/23/2022
• Supplement Dates FDA Received: 05/22/2022; 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• 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 KIT-WW; THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F; UNKNOWN CABLE