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

Catalog Number D139401

Device Problems Coagulation in Device or Device Ingredient (1096); Obstruction of Flow (2423)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter and clot was observed.It was reported that char was confirmed at the end of the right pulmonary vein (rpv) isolation.Subsequently, ablating at left pulmonary vein (lpv) three times and then found the char again.They wiped it off and continued to perform one more ablation, ¿but again found a clot¿.The char was found at the tip electrode, on the proximal side, around the electrode.The system did not present any error messages.Heparinized saline was used.The qdot micro catheter was replaced.Thereafter, ablation was performed at 90 w only at superior vena cava (svc).Reproducibility in the left atrium was not confirmed.The anticoagulation therapy was done and the activated clotting time (act) is 298.No adverse patient consequence was reported.The physician was concerned about the char itself, however, did not mention about the amount.The physician commented that insufficient irrigation at 90w may be causing the char on the proximal side of the electrode tip.An ngen generator and pump were used and the correct catheter settings were selected.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.

Manufacturer Narrative

E 1.Initial reporter phone: (b)(6).The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, the manufactured and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter and clot was observed.It was reported that char was confirmed at the end of the right pulmonary vein (rpv) isolation.Subsequently, ablating at left pulmonary vein (lpv) three times and then found the char again.They wiped it off and continued to perform one more ablation, ¿but again found a clot¿.The char was found at the tip electrode, on the proximal side, around the electrode.The system did not present any error messages.Heparinized saline was used.The qdot micro catheter was replaced.Thereafter, ablation was performed at 90 w only at superior vena cava (svc).Reproducibility in the left atrium was not confirmed.The anticoagulation therapy was done, and the activated clotting time (act) is 298.No adverse patient consequence was reported.The physician was concerned about the char itself, however, did not mention about the amount.The physician commented that insufficient irrigation at 90w may be causing the char on the proximal side of the electrode tip.An ngen generator and pump were used and the correct catheter settings were selected.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature, impedance, and patency test of the returned device were performed following bwi procedures.Visual analysis revealed thrombus residues in the dome of the device.A temperature and impedance test were performed, and the results were found within specifications.No temperature or impedance issues were observed.A patency test was performed, and the device was partially flushing.Further investigation revealed that thrombus residues were occluding the irrigation holes.A manufacturing record evaluation was performed for the finished device number lot 31103149l and no internal action related to the complaint was found during the review.Since the presence of thrombus was observed, this failure could be related to both issues reported by the customer.Therefore, the customer complaint was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and increased risk for collateral damage.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(b)(4).

• 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: 18406398
• MDR Text Key: 331509467
• Report Number: 2029046-2023-03094
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: 10846835017045
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139401
• Device Lot Number: 31103149L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK_CARTO 3.; UNK_NGEN PUMP.; UNK_NGEN RF GENERATOR.
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 47 KG