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

Catalog Number D139505

Device Problems Coagulation in Device or Device Ingredient (1096); Insufficient Cooling (1130)

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

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a qdot micro catheter and a thrombus and/or clot issue occurred.Initially it was reported when coming on ablation, for the first time, the ngen generator displayed an "electrode temperature slope too high." they checked all the cable connections for the ngen and qdot micro catheter.The qdot micro catheter was flushed without resolution.The physician then removed the qdot micro catheter from the body, and it was noticed that there was blood residue present on the tip of the catheter.The qdot micro catheter was flushed again and the physician tried to wipe off the qdot micro catheter, but the blood residue was still present.The caller noted that the act's were therapeutic.The qdot micro catheter was replaced and the issue was resolved.The procedure continued.There was no patient consequence reported.Additional information was received on 28-feb-2024 stating that the blood residue present on the tip of the catheter appeared to be thrombus and/or clot.It was on the side of the tip electrode.Not at the exact tip itself.No symptoms, procedure continued without incident.The physician was surprised that it clotted off so quickly after only being in the left atrium for about 15 minutes.The physician did not consider the amount of thrombus / clot observed caused a potential risk to this patient.No cut off values were exceeded.Generator parameters were set at qmode, temperature cut off 55, and max low flow temperature at 42 degrees c.The correct catheter settings were selected on the generator.The irrigation rate was not used outside of those prescribed.Pre-ablation flow rate was 2 seconds (default setting on monitor).The average contact force was not greater than 25 grams.The duration of ablation both times coming on were less than 1 second.The pump was switching from ¿low¿ to ¿high¿ flow during ablation, but they were not on ablation long enough for the flow rates to change.Carto did not display any error messages, just the ngen monitor displayed: stop reason: electrode ¿ temperature slope too high.There were no issues related to temperature or flow on the catheter.The patient was anticoagulated.Recommended normal heparinized saline was used.The act practice of the physician is >350.The act was maintained throughout the case.There was one noted to be at 349 before the issue was noted.The other two were 363 and 371.This event was originally considered non-reportable, however, bwi became aware of additional information stating it appeared to be thrombus and/or clot on 28-feb-2024 and have assessed this issue as reportable as of 28-feb-2024.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 19-mar-2024.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 19-mar-2024, noted corrections to the 3500a initial.G3.Date received by manufacturer was processed as 23-feb-2024 and it should have been 28-feb-2024.-] h10.Additional manufacturer narrative should have included: 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.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a qdot micro catheter.Initially it was reported when coming on ablation, for the first time, the ngen generator displayed an "electrode temperature slope too high." they checked all the cable connections for the ngen and qdot micro catheter.The qdot micro catheter was flushed without resolution.The physician then removed the qdot micro catheter from the body, and it was noticed that there was blood residue present on the tip of the catheter.The qdot micro catheter was flushed again and the physician tried to wipe off the qdot micro catheter, but the blood residue was still present.The caller noted that the act's were therapeutic.The qdot micro catheter was replaced and the issue was resolved.The procedure continued.There was no patient consequence reported.Additional information was received.The blood residue present on the tip of the catheter appeared to be thrombus and/or clot.It was on the side of the tip electrode.Not at the exact tip itself.No symptoms, procedure continued without incident.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 25-mar-2024, a hole on the surface with reddish material inside the pebax was observed.The returned condition of a hole on the surface of the pebax was also assessed as mdr reportable.The awareness date for this bwi lab finding is 25-mar-2024.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, patency, temperature and impedance test of the returned device were performed following bwi procedures.Visual inspection was performed and no char, thrombus or clot residues were observed during the inspection; however, a hole on the surface with reddish material inside the pebax was observed.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 batch number, and no internal actions were identified.The thrombus/clot issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.In the other hands, the temperature issue reported by the customer was confirmed, the foreign material inside the pebax could be the root cause of the high temperature reported by the customer.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.The instructions for use contain the following recommendations: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.In relation to the pebax's damage, the instructions for use contain the following recommendations: to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.After insertion, slide the insertion tube back toward the handle.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.Explanation of codes: investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿thrombus and/or clot¿.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 customer¿s reported, the ¿ngen generator displayed an electrode temperature slope too high." in addition, the biosense webster inc.Analysis finding of ¿a hole on the surface with reddish material inside the pebax¿.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
• 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: 18927435
• MDR Text Key: 337953868
• Report Number: 2029046-2024-00899
• 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,Followup,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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: 31237994L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2024
• 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 PUMP, US CONFIGURATION; NGEN RF GENERATOR, US; UNK IRRIGATION TUBING; UNK_CARTO 3