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

Catalog Number D139505

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Arrest (1762)

Event Date 11/23/2023

Event Type  Injury  

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31155602l number, and no internal action related to the complaint was found during the review.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

During a clinical trial, it was reported that a patient underwent an index cardiac ablation for an atrial fibrillation (afib) and ischemic ventricular tachycardia on 23-nov-2023 with a qdot micro catheter.On 23-nov-2023, patient experienced worsening of a pre-existing condition ventricular fibrillation categorized as severe and serious defined by a serious deterioration in health with in-patient or prolonged hospitalization admission date of (b)(6) 2023 and discharge (b)(6) 2023.Relationship to study device is not related and relationship to primary study procedure is causal to the index procedure.The serious and procedure related event is categorized as expected/anticipated.The outcome is recovering/resolving.The intervention was cpr after cardioversion for fv during final testing and rosc (return of spontaneous circulation) within 2 minutes.

• 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: 18365893
• MDR Text Key: 331008356
• Report Number: 2029046-2023-03021
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 31155602L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2023
• 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: OCTA,LNG,48P,2-5-2-5-2,F-CURVE; UNK GENERATOR; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 73 KG