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

Catalog Number D133604IL

Device Problems Crack (1135); Failure to Sense (1559)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a superventricular tachycardia (svt) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter during which device damage and a force sensor error were noted.It was reported that during the operation, error 106 was displayed on the carto system.The spring area of the device was found damaged after removing the device from the patient.A second device was used to complete the operation.There was no adverse event reported on patient.A photo provided by the customer revealed that the spring area of the device had a broken pebax.The force sensor error is not mdr-reportable.The broken pebax is mdr-reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The bwi lab also received photographs of the complaint device as well.The analysis has begun for both the photos and the physical device but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 5-sep-2023, the photo analysis was completed.It was reported that a patient underwent a superventricular tachycardia (svt) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter during which device damage and a force sensor error were noted.It was reported that during the operation, error 106 was displayed on the carto system.The spring area of the device was found damaged after removing the device from the patient.A second device was used to complete the operation.There was no adverse event reported on patient.Device investigation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, alert 106 "force catheter sensor error" was observed on carto 3 screen. the physical device was not observed on the picture provided and physical damage on the pebax section cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31051150m and no internal actions related to the complaint were found during the review.The customer complaint was confirmed based on the picture received.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¿ ELECTROPHYSIOLOGY 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17668275
• MDR Text Key: 322885571
• Report Number: 2029046-2023-01978
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133604IL
• Device Lot Number: 31051150M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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