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); Electrical Shorting (2926)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30418312m number, and no internal action related to the complaint was found during the review.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 when connected the thermocool® smart touch® sf bi-directional navigation catheter to the patient interface unit (piu), error 7 ¿current leakage¿ was displayed.The error was displayed due to a signal loss in all channels (ic and bs) and both systems (carto 3 and ep recording).The physician did not have any electrocardiogram (ecg) signal available to monitor the patient¿s heart rhythm at the time of the issue.The ablation cable was replaced but the issue did not resolve.The catheter was replaced and the issue successfully resolved.The procedure continued.No patient consequences were reported.The current leakage is not an mdr-reportable issue.However, the lack of monitoring of cardiac rhythm is an mdr-reportable event.

Manufacturer Narrative

On 3/18/2021, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that when connected the thermocool® smart touch® sf bi-directional navigation catheter to the patient interface unit (piu), error 7 ¿current leakage¿ was displayed.The error was displayed due to a signal loss in all channels (ic and bs) and both systems (carto 3 and ep recording).The physician did not have any electrocardiogram (ecg) signal available to monitor the patient¿s heart rhythm at the time of the issue.The ablation cable was replaced but the issue did not resolve.The catheter was replaced and the issue successfully resolved.The procedure continued.No patient consequences were reported.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted visual inspection and electrical evaluation of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the smart touch sf catheter.An electrical and carto test were performed on the catheter and it was found within specifications.No electrical malfunction was observed.A manufacturing record evaluation was performed for the finished device 30418312m number, and no internal action related to the complaint was found during the review.The instructions for use contain the following warning stated in the carto 3 system manual: perform the following to determine if the problem was caused by one of the catheters or their extension cables, by the body surface ecg cable, or by the patient interface unit (piu): 1.Immediately disconnect body surface ecg cable and all catheter extension cables from the piu.2.Press acknowledge in the caution window, to enable ablation through the piu.3.If the error persists, shut down the piu and contact biosense webster service and support department.4.If the error message has disappeared, reconnect the body surface ecg cable and catheters, one by one, until catheter or cable causing the leakage is identified.5.Replace the faulty item.6.If the error returns during ablation, disconnect all catheter cables and the body surface ecg cable from the piu, turn off the piu power supply, and contact biosense webster service and support department to report a piu issue.The event described could not be confirmed as the device performed without any electrical issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10849418
• MDR Text Key: 238136592
• Report Number: 2029046-2020-01763
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30418312M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNK ABLATION CATHETER CABLE; UNSPECIFIED ABLATION CATHETER; UNSPECIFIED EP RECORDER