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

Model Number D134702

Device Problems Signal Artifact/Noise (1036); Erratic or Intermittent Display (1182); Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

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

Event Date 05/16/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter left (l-afl) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax.It was initially reported by the customer that when coming on ablation, the visualization of the thermocool® smart touch® sf uni-directional navigation catheter would jump and move around on the screen, on the carto 3 system.The caller also reported that there was noised displayed on the distal ablation signals, on the carto 3 system and recording system, simultaneously.The cable was replaced without resolution.The smarttouch sf catheter was removed from the body, and it was noticed there was blood inside the thermocool® smart touch® sf uni-directional navigation catheter tip.The thermocool® smart touch® sf uni-directional navigation catheter was replaced and the issue resolved.The procedure continued.The caller reported the carto 3 system is operating per specs and is not responsible for the product issue.The customer¿s reported issues of the spinning icon, noise and foreign material inside the catheter tip are not considered to be mdr reportable since the potential that these could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On (b)(6) 2022, the bwi pal revealed that a visual inspection of the returned device found a hole in the pebax of the thermocool® smart touch® sf uni-directional navigation catheter.This finding was reviewed and determined to be an mdr reportable malfunction.

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection, eeprom, magnetic and electrical test of the returned device.Visual analysis of the returned sample revealed a hole in the pebax of the thermocool® smart touch® sf uni-directional navigation catheter.The magnetic sensor functionality test was performed, per bwi procedures.No magnetic sensor issues were observed.During the magnetic sensor functionality test, the device was displayed correctly.Eeprom integrity test was performed, with acceptable results.An electrical test was performed in accordance with bwi procedures.The catheter passed the electrical values within specification.Even though no electrical or magnetic issues were found, the blood inside the pebax could have induced the electrical and magnetic issues.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 devices are manufactured, inspected, and released to approved specifications.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.The instructions for use contain the following warning stated in the carto 3 system manual: before use, check irrigation ports are patent by infusing heparinized normal saline through the catheter and tubing.Also, do not continue the use of the catheter if is not functioning properly or present physical damage.To minimize ecg noise, the following guidelines should be followed.Ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.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 UNI-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 ; 646591-798
• MDR Report Key: 15189433
• MDR Text Key: 302930813
• Report Number: 2029046-2022-01818
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2023
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30745018L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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; SL0 8.5 FRENCH SHEATH