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

Catalog Number D133602

Device Problems Obstruction of Flow (2423); Positioning Problem (3009)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a redo atrial fibrillation cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and there was no irrigation through ablation catheter and broken flex.It occurred after the device was used on the patient.Ablation was already performed before the issue started.They tried to flush both with the pump and with a syringe directly on the catheter, however, it was impossible to get water through the catheter.When the catheter was replaced, the issue was resolved.There was no patient consequence.

Manufacturer Narrative

E 1.Initial reporter phone : (b)(6).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 31132338m and no internal action related to the complaint was found during the review.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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

It was reported that a patient underwent a redo atrial fibrillation cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and there was no irrigation through ablation catheter and broken flex.It occurred after the device was used on the patient.Ablation was already performed before the issue started.They tried to flush both with the pump and with a syringe directly on the catheter, however, it was impossible to get water through the catheter.When the catheter was replaced, the issue was resolved.There was no patient consequence.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual and x-ray inspections, deflection and irrigation tests of the returned device were performed in accordance with bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device failed the flow pump test as high-pressure values were observed.A deflection test was performed, and the device failed to meet the curve specifications.An x-ray inspection was performed, and the puller wire was observed loose at the handle area.A manufacturing investigation was initiated, and it was found that the puller wire was entangled with the other components of the device including the irrigation tube due to an omission of the process.An awareness session was performed for all the personnel involved.A manufacturing record evaluation was performed for the finished device number lot 31132338m and no internal action related to the complaint was found during the review.The irrigation and deflection issues reported by the customer were confirmed.The instructions for use contain the following recommendations: flush the catheter with heparinized saline prior to insertion into the body.Do not manually pre-shape the distal shaft of the catheter by applying external forces intended to bend or affect the intended shape or curve of the catheter.Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.Do not use the catheter without irrigation flow.This product issue will be addressed through bwi's quality system.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: 18753425
• MDR Text Key: 336966618
• Report Number: 2029046-2024-00578
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133602
• Device Lot Number: 31132338M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK_NGEN PUMP.; UNK_NGEN RF GENERATOR.