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

Model Number D134701

Device Problems Break (1069); Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It was reported that the patient underwent an unspecified ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the map was very confused and didn't provide the medical team any correct information.Neither the representation nor the alignment nor the contact pressure were correct.After the doctor pulled out the catheter, the medical team noticed that the tip of the ablation catheter was broken off.No fragments were generated.The damage did not resulted in sharp or lifted rings.There was no resistance or difficulty during insertion or removal of the catheter.The device was replaced and the procedure continued.The procedure was successfully completed.No patient consequences were reported.Broken tip is mdr-reportable.

Manufacturer Narrative

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 (b)(6) 2023, the product investigation was completed as the complaint device was not returned.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 number lot 30965979l and no internal actions 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).

Manufacturer Narrative

On 27-jul-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that the patient underwent an unspecified ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the map was very confused and didn't provide the medical team any correct information.Neither the representation nor the alignment nor the contact pressure were correct.After the doctor pulled out the catheter, the medical team noticed that the tip of the ablation catheter was broken off.No fragments were generated.The damage did not resulted in sharp or lifted rings.There was no resistance or difficulty during insertion or removal of the catheter.The device was replaced and the procedure continued.The procedure was successfully completed.No patient consequences were reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation, magnetic sensor functionality and screening test of the returned device were performed following bwi procedures.Visual inspection revealed that the pebax was broken in two areas leaving exposed wires; however, the rest of the tip was inspected and no broken condition was observed.The magnetic and the force features were tested and no visualization issues were observed; however, during the analysis, hi force was detected to an internal circuit printed board (pcb) issue.Also, no impedance and no temperature were detected due to open circuits in the tip area.A manufacturing record evaluation was performed for the finished device number lot 30965979l and no internal actions related to the complaint was found during the review.The force issue and broken tip reported by the customer were confirmed.Since an internal pcb failure was detected, the visualization issue was also confirmed.The root cause of the pebax damage could be related to the excessive force or manipulation of the device during the procedure; however, this can not be conclusively determined.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17062503
• MDR Text Key: 316593583
• Report Number: 2029046-2023-01224
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• 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: 08/22/2023

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 Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30965979L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/09/2023; 07/27/2023
• Supplement Dates FDA Received: 07/07/2023; 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2023
• 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