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

Catalog Number D134721IL

Device Problem Signal Artifact/Noise (1036)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that during the operation, the signal interference (noise)was observed on intra cardiac (ic) channels on the carto 3 system.A second device was used to complete the operation.There was no adverse event reported on patient.The issue occurred while the affected catheter was inside the patient¿s body but the physician did have another ecg signal available to monitor the patient¿s heart rhythm.The customer¿s reported issue of signal interference is not considered to be mdr reportable since the risk to the patient is low.On (b)(6) 2023, the bwi pal revealed that a visual inspection of the returned device found a hole on the pebax with reddish-brown material.These finding were reviewed and assessed the issue of a ¿hole¿ in the pebax as an mdr reportable malfunction since the integrity of the device has been compromised.

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation.A visual inspection, electrical evaluation and cool flow pump and pressure gage test of the returned device were performed following bwi procedures.The evaluation has been completed.Visual analysis revealed a hole on the pebax with reddish-brown material.An electrical test was performed, and current leakage has been detected.Due to this finding, the device was connected to the pump for 30 minutes, and no water leakage was observed.Then, the device was dissected and no corrosion was found.Therefore, the root cause of the damage on the pebax and current leakage issue could not be conclusively determined, but it was concluded that it occurred outside the bwi manufacturing facilities and could be related to the failure described by the customer.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.Additionally, a picture of the complaint device was provided by the customer to aid in the investigation.The picture was evaluated following biosense webster's procedures.According to pictures provided by the customer, a signal noise was observed on carto 3 screen.The customer complaint was also confirmed based on the picture received.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.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 ref.# (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: 17652161
• MDR Text Key: 322306671
• Report Number: 2029046-2023-01934
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Catalogue Number: D134721IL
• Device Lot Number: 31009556L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM