MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139505

Device Problems Insufficient Cooling (1130); Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Deformation (2976)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to biosense webster (bwi) for evaluation.A visual inspection and functional tests of the returned device were performed following bwi procedures.Visual analysis revealed reddish material and a hole on the pebax with internal parts exposed.The device was connected to the carto 3 system, the device was visualized and recognized correctly.In addition, an ablation cycle was intended, however, it was not possible since no temperature was displayed on the generator due to an open circuit on the tip area.Since an ablation could not be performed, no force issues were observed.The root cause of the damage on the pebax could be related to the handling, since in the process, there are control inspection points to avoid this kind of issue; however, this could not be conclusively determined.A manufacturing record evaluation was performed for the finished device 31061610l number, and no internal actions related to the reported complaint condition were identified.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a qdot micro¿ catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially it was reported that when they were in q-mode plus upon coming on ablation, they received a force reading error coming from the ablation catheter.To troubleshoot, they re-zeroed the catheter multiple times, and every time they did, the force readings would slowly creep up to 6 or 7 grams of force.They replaced the catheter cable with no resolution.They rebooted the ngen generator with no resolution.At this point, there was no error code or messages on the carto 3 system.They then pulled the qdot catheter out of the patient¿s body and noticed that the tip of the catheter "looked like it was a little off with the spring".They replaced the catheter which resolved the force issue.However, they then noticed issues with the temperature reading coming from the catheter.They received a white heat map on the carto 3 system catheter view.They then rebooted the ngen generator and the temperature reading issue was resolved.Upon coming onto ablation after zeroing the catheter, the ngen provided an error message stating "electrode temperature slope too high".At this time, the catheter was providing readings of temperatures of about 37 to 40 degrees celsius and when they would come on ablating, the temperature would drop down to 30 degrees celsius.They then switched from q-mode plus to q-mode with no resolution.They rebooted the ngen generator and on the carto 3 system, they received "error 170: electrode temperature fault".They replaced the qdot catheter with a thermocool smarttouch sf (stsf) catheter, and the issue was resolved, and the procedure continued.No adverse patient consequence was reported.A field service engineer was requested for follow-up with the ngen generator.The high temperature, force issue, and the issue with tip of the catheter "looked like it was a little off with the spring" were assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and a hole on the pebax with internal parts exposed were observed.The hole in the pebax was assessed as mdr reportable.

• Brand Name: QDOT MICRO¿ CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 18223507
• MDR Text Key: 329819084
• Report Number: 2029046-2023-02770
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210027
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 31061610L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2023
• 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: NGEN RF GENERATOR, US; QDOT MICRO, BI, TC, D-F; UNK BRAND CABLE; UNK BRAND CABLE; UNK BRAND GENERATOR; UNK_CARTO 3; UNK_CARTO VIZIGO SHEATH; UNK_THERMOCOOL SF NAV