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

Catalog Number D134701

Device Problems Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895); Device Sensing Problem (2917)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, screening, temperature and impedance test of the returned device were performed following bwi procedures.Visual inspection was performed a hole on the surface with reddish material inside the pebax was observed.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.The magnetic and force feature were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.The hole on the surface of the pebax could be related to the manipulation of the device during the procedure.However, this can not be conclusively determined.A manufacturing record evaluation was performed for the finished device number lot 31033864l and no internal actions related to the complaint were found during the review.The issues reported by the customer were confirmed, the foreign material inside the pebax could be the root cause of the force and temperature issues reported by the customer.The instructions for use contain the following recommendations for temperature: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.And for force: 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.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).

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and post procedure the bwi product analysis lab identified a hole on the surface of the pebax.During the procedure, when the catheter was inserted into the la (left atrium), the temperature measuring was not working properly (temperature varied permanently).Temperature measurement was not working properly.Temperature changed constantly from high to low values.No ablation took place, catheter was flushed only and directly changed afterwards.The force measurement was not working properly as well.It was impossible to zero the catheter properly.After removing catheter from patients heart, blood was observed in catheter tip.The catheter was changed to another one and the procedure continued.No patient consequences were reported.The force issue is not mdr-reportable.The temperature issue is not mdr-reportable.The blood in the catheter tip is not mdr-reportable.The pebax hole is mdr-reportable.

• 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: 17774955
• MDR Text Key: 323748674
• Report Number: 2029046-2023-02121
• Device Sequence Number: 1
• Product Code: LPB
• 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: Physician
• Type of Report: Initial
• Report Date: 09/19/2023

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 Catalogue Number: D134701
• Device Lot Number: 31033864L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2023
• 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