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

Model Number D134805

Device Problems High Readings (2459); Contamination /Decontamination Problem (2895); Electrical Shorting (2926)

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

Event Date 11/16/2022

Event Type  malfunction  

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).

Event Description

It was reported that an unknown patient underwent an afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.It was reported that the carto 3 system displayed high-force warnings when going on ablation and when the catheter was floating in the heart.They exchanged the cable and then they removed the catheter and inspected it and saw blood in the lumen of the catheter.The catheter was exchanged, and the issue was resolved.The replacement catheter displayed a current leakage error (7).The cable was exchanged, and the issue persisted.The ablation catheter was exchanged, and the issue was resolved.Patient has not exhibited any neurological symptoms since the procedure was completed.No patient consequences were reported.The medical team confirmed that it was fluid not a clot or char or thrombus that was found in the lumen of the catheter.It was a vizigo sheath that was used.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The catheter pebax was not physically damaged.No available pictures.The "current leakage error" was not accompanied by a signal noise / signal loss issue.Current leakage-device disruption is not mdr-reportable.Force high is not mdr-reportable.Foreign material on usable length of catheter is mdr-reportable.

Manufacturer Narrative

On 19-dec-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: visual analysis revealed damage in the pebax surface, no exposed internal components were observed.A microscopic examination was performed in the pebax area.It was observed wrinkled surfaces on the pebax surface.For this observed issue, sem analysis was performed to confirm the damage observed in the affected surface, and it confirmed evidence of mechanical damage on the pebax surface.No hole or foreign material stuck in the area was observed, additionally, a polyurethane application (pu) was missing on the electrode edge.The cause of the foreign material issue reported by the customer could be related to the findings previously analyzed in the pebax; however, this cannot be concluded.A screening test was performed and the device was recognized correctly; no current leakage error was displayed; however, hi force appeared due to corrosion on the pc board.The failures reported by the customer could be related to an internal pcb corrosion issue.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: if force readings might be inaccurate or another catheter is in proximity: an alert message appears, force readings on the dashboard are displayed in gray, and the force graph is colored white.Resolve the issue according to the directions in the alert message to enable force measurement.You can also continue the study without force data.To minimize current leakage, the following guidelines should be followed.Immediately disconnect the body surface ecg cable and all catheter extension cables from the piu (patient interface unit).Press acknowledge in the caution window, to enable ablation through the piu.Do not immerse the handle or the cable connector in fluids; electrical performance could be affected all units are inspected before 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.A manufacturing record evaluation was performed for the finished device 30907632l number, and no internal action 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).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-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: 15983548
• MDR Text Key: 308563109
• Report Number: 2029046-2022-03124
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2023

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: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30907632L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• 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; THERMOCOOL SMARTTOUCH; VIZIGO SHEATH