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

Catalog Number D134805

Device Problems Erratic or Intermittent Display (1182); Contamination /Decontamination Problem (2895)

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax with internal parts exposed.It was initially reported by the customer that while attempting to apply rf ablation, the ablation catheter would be displayed as "jumping" on the carto 3 system.The caller confirmed that the catheter would not be jumping within the patient's heart.The caller noted that an error 401 map points cannot be acquired message would be displayed intermittently.The caller exchanged the ablation catheter and the issue resolved.The caller stated that when the physician removed the faulty catheter from the patient, they noticed blood within the clear distal portion of the catheter tip.There was no patient consequence.Additional information received indicated there was no damage that resulted in wires being exposed, no sharp or lifted rings and no resistance during insertion or removal of the catheter.The issue was within the clear window of the distal tip and the catheter was not pre-shaped.The customer¿s reported jumping and error 401 issues are not considered to be mdr reportable since these are highly detectable issues.There is no real movement of the catheter.The most likely consequence is an intraprocedural delay.The potential risk that these could cause or contribute to a serious injury or death is remote.On 25-sep-2023, the bwi pal revealed that a visual inspection of the returned device found a reddish brown material inside and a hole on the pebax with internal parts exposed.These findings 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 device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and magnetic sensor functionality test of the returned device were following bwi procedures.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed.A magnetic sensor functionality test was performed, and the device was recognized on the system; however, error 105 was displayed on the screen due to an open circuit in the tip area.The foreign material described by the costumer was confirmed; and the blood inside the pebax area found could be related to the icon jumping.The instructions for use contain the following recommendations: improperly positioned patches may increase the chances of a virtual magnetic reference move unrelated to patient movement.This could also result in inaccurate catheter visualization.A manufacturing record evaluation was performed for the finished device, and no internal action related to the complaint were found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications, therefore no corrective action and preventive action (capa) activity is required now.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the issue of hole in the pebax.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer's reported issue of jumping and error issues.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 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: 17959727
• MDR Text Key: 325974639
• Report Number: 2029046-2023-02362
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31080484L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• 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
• Treatment: CARTO 3 SYSTEM; UNK_CARTO VIZIGO SHEATH; UNK_OPTRELL MAPPING CATHETER