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

Model Number D134805

Device Problems Device Contamination with Body Fluid (2317); High Readings (2459)

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

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the complaint device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and functional tests of the returned device were performed following bwi procedures.Char residues were not observed on the catheter tip, this could be related to the decontamination process.Temperature and impedance tests and cool pump flow and pressure gauge tests were performed, and the device was found working correctly.The pebax area was observed under a microscope and a hole was found with blood inside the pebax area.The blood found could be related to the customer¿s reported issues; the customer complaint was confirmed.Additionally, the customer provided pictures of the complaint device to aid in the investigation process.The picture was reviewed following biosense webster's procedures.According to the pictures received, char was observed on catheter tip, this condition could be related to the impedance issue reported by the customer, however this cannot be conclusively determined.Also, blood was observed inside the pebax component, however no external damages were observed on the pebax.The customer complaint was also confirmed based on the pictures received.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.To minimize no temperature issue, the following guidelines should be followed.Monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation.If temperature increases to 40°c during rf energy delivery, power delivery should be interrupted.Char is a physical phenomenon of radiofrequency; it can be the usual result of the ablation process; however, the instructions for use contain the following instruction: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.As part of bwi'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.# pc-(b)(4).

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.It was initially reported by the customer that the impedance reading on the carto 3 system was steadily rising, and would not decrease.The catheter was removed from the body, and char was noticed on the tip of the thermocool® smart touch® sf bi-directional navigation catheter.The catheter was replaced and the issue resolved.There were no noticeable issues with temperature or flow.The smartablate generator had the correct catheter settings and was set at 50 watts for 10 seconds with default settings for impedance cut off and the smartablate pump was switching appropriately from ¿low¿ to ¿high¿ flow during ablation.Irrigation was set to default.Patient was anti-coagulated and typical practice for physician is target 300 act which was maintained throughout the case.Average ablation session was 13 seconds.Average force did not exceed 40, between 10-20.Pre-ablation setting was not changed.Heparinized normal saline was used.Carto visitag module was used with visitag settings were set for surpoint (respiration, 3mm, 3sec, 25g, 3sec).Color options were used prospectively was impedance-custom (5-10).Impedance cut off was not exceeded and the operator stopped ablation to check catheter tip.Patient did not have any consequences.There was no noticeable impedance change when maneuvering the catheter and the catheter did not appear to be damaged.The customer¿s reported issue of high impedance is not mdr reportable since the user-defined cut-off was not exceeded the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.The customer¿s reported issue of foreign material inside the pebax, but no visible damage is not considered to be mdr reportable since there is no damage to the pebax integrity that could cause the foreign material to travel into the blood circulation.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The customer¿s reported issue of char is not mdr reportable since char is a physical phenomenon of rf energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.In addition, biosense webster inc.Has reassessed the reportability of char-related events and has determined that these events, which were previously reported as malfunctions, are ¿not reportable.¿ the fda has provided documented concurrence with this assessment.On 14-oct-2022, the bwi pal revealed that a visual inspection of the returned device found a hole in the pebax area.This finding was reviewed and determined to be mdr reportable.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 14-oct-2022 and reassessed it as mdr reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 17-nov-2022, it was noticed the following codes were inadvertently omitted from the 3500a initial mdr which were selected as related to the char issue observed on the pictures provided by the customer.These have now been added to the appropriate fields: h6.Investigation findings - problem due to thrombosis activation (c010604).H6.Investigation conclusions - cause not established (d15).H6.Component code - cautery tip (g01002).

• 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: 15765725
• MDR Text Key: 307210461
• Report Number: 2029046-2022-02789
• 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,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• 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: 30837460L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2022
• 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: ABBOTT SJM AGILIS SHEATH.; CARTO 3 SYSTEM.; SMARTABLATE GENERATOR SPARE-US.; SMARTABLATE PUMP SPARE-US.