MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, UNI-DIRECTIONAL, D CURVE, C3, SPLIT HANDLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139401

Device Problems Insufficient Cooling (1130); Contamination /Decontamination Problem (2895)

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

Event Date 07/14/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) - persistent ablation procedure with a qdot-micro, uni-directional, d curve, c3, split handle and the membrane on the tip of the qdot catheter did not appear "normal"--it looked like there was some soft of material inside the catheter.The membrane surrounding the tip of the catheter appeared to be compromised and noticed that there was blood embedded within the tip.No foreign material was seen apart from the blood (from the patient's body).When the medical team tried to engage ablation, the temperature sloped too high and an error was displayed on the ngen generator, resulting in the radiofrequency (rf) cutting off.Rf was terminated almost immediately when attempting to ablate--the system terminated ablation upon alerting.Nominal cut off values were used on ngen.The generator parameters were as follows: the system was set up for qmode+ (90 w for 4 seconds).Power max 90 w.Temperature target: 60 c cutoff: 65 c.The catheter was replaced and the issue was resolved.The case continued.No patient consequences were reported.High temperature is not mdr-reportable.The soft material found inside the catheter is mdr-reportable.

Manufacturer Narrative

The bwi product analysis lab received photos of the complaint device for evaluation.The photo analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 31007133l, and no internal action related to the complaint was found during the review.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.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

On 15-aug-2023, the photo analysis was completed.It was reported that a patient underwent an atrial fibrillation (afib) - persistent ablation procedure with a qdot-micro, uni-directional, d curve, c3, split handle and the membrane on the tip of the qdot catheter did not appear "normal"--it looked like there was some soft of material inside the catheter.The membrane surrounding the tip of the catheter appeared to be compromised and noticed that there was blood embedded within the tip.No foreign material was seen apart from the blood (from the patient's body).Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, reddish-brown material was observed inside the pebax of the catheter; however no external damages were observed on the device.The photo does not provided sufficient information related to the temperature issue reported by the customer, and therefore no results can be obtained from it.A manufacturing record evaluation was performed for the finished device number 31007133l, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.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

On 21-sep-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation (afib) - persistent ablation procedure with a qdot-micro, uni-directional, d curve, c3, split handle and the membrane on the tip of the qdot catheter did not appear "normal"--it looked like there was some soft of material inside the catheter.The membrane surrounding the tip of the catheter appeared to be compromised and noticed that there was blood embedded within the tip.No foreign material was seen apart from the blood (from the patient's body).Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, patency and temperature, and impedance test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.A patency test was performed and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device 31007133l number, and no internal actions related to the reported complaint condition were identified.The reddish material inside the pebax could be related to the high-temperature issue reported by the customer; therefore, both issues reported were confirmed.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: QDOT-MICRO, UNI-DIRECTIONAL, D CURVE, C3, SPLIT HANDLE
• 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: 17514535
• MDR Text Key: 321065618
• Report Number: 2029046-2023-01764
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: 10846835017045
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: 31007133L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• 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.; NGEN GENERATOR.; OCTARAY CATHETER.; SOUNDSTAR CATHETER.