MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133602

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the device was visually inspected, and it was found in good condition.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.A manufacturing record evaluation was performed for the finished device 30195733m number, and no internal actions related to the reported complaint condition were identified.The customer complaint cannot be confirmed.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter wherein a current leakage error was displayed and all electrocardiogram (ecg) signals were lost.Initially it was reported an error 7, leakage current, was detected on the patient interface unit (piu) rl input.The connector was changed but the error was still present.The catheter was changed.No patient consequence was reported.Additional information was received on february 3, 2020, confirming that during the procedure, signal loss was experienced on all channels (body surface and intracardiac).The physician did not have any ecg signals available to monitor the patient¿s heart rhythm.The interference was observed on the carto® 3 system and the recording system.The current leakage error and the procedure delay are to be considered non-mdr reportable since the potential risk that any of these could cause or contribute to a death or serious deterioration in state of health is remote.The loss of all ecg signals has been assessed as mdr reportable.This event was originally considered not mdr reportable, however, biosense webster, inc.Became aware of a reportable malfunction on february 3, 2020 and have reassessed this complaint as reportable.Therefore, the awareness date for this reportable finding is february 3, 2020.On december 6, 2019, the biosense webster, inc.Product analysis lab received the device for evaluation, and it was noted that upon initial visual inspection, there was no damages or anomalies that were observed.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9764664
• MDR Text Key: 195729672
• Report Number: 2029046-2020-00305
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2020
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Device Lot Number: 30195733M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2019
• 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