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

Catalog Number D139504

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial flutter ablation with a qdot micro¿ catheter and carto vizigo¿ 8.5f bi-directional guiding sheath - large and the patient experienced pericardial effusion that required pericardiocentesis.The physician noted that the patient's blood pressure was dropping.A soundstar catheter was used to check the heart, and a pericardial effusion was identified.A pericardiocentesis was performed.The patient was stable condition and did not require surgery.The physician thought the issue occurred either during transseptal access with vizigo or during qmode + with qdot on lateral mitral line.The patient condition was 'fine' and the physician was unsure of the cause of the adverse event.The physician hypothesizes that a possible cause of the effusion was due to him exerting too much force on the vizigo while going transseptal.Intervention was pericardiocentesis and monitored to make sure it didn't get worse, which it didn't.Patient did not required an extended hospitalization.Patient fully recovered.Transseptal puncture was performed using baylis versacross fixed sheath and ts needle.Ablation was performed prior to noting the pericardial effusion.No steam pop was noted.The event occurred during transseptal phase, however, the medical team had already burned on the left side due to a patent foramen ovale (pfo), however the physician did not feel like he had enough stability so after doing what he could, he performed a transseptal puncture and the pe (pericardial effusion) was noted shortly after.No errors observed on bwi equipment during the procedure.

Manufacturer Narrative

The bwi 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.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).Biosense webster manufacturer's reference number (b)(4) has 2 reports.Manufacturer report number for the qdot micro¿ catheter.Manufacturer report number 2029046-2024-00808 for the carto vizigo¿ 8.5f bi-directional guiding sheath - large.

Manufacturer Narrative

On 15-mar-2024, bwi received additional information indicating that the complaint device's lot number is 31191837l, which has been updated in section d4.On (b)(6) 2024, the product investigation was subsequently completed.Device evaluation details: visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device 31191837l number, and no internal action related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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¿ CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 18888923
• MDR Text Key: 337479865
• Report Number: 2029046-2024-00807
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835016741
• UDI-Public: 10846835016741
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139504
• Device Lot Number: 31191837L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2023
• 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: BAYLIS VERSACROSS NEEDLE; CARTO 3 SYSTEM WITH VISITAG; NGEN GENERATOR; SOUNDSTAR CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention