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

Catalog Number UNK_QDOT MICRO

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Transient Ischemic Attack (2109); Cardiac Tamponade (2226)

Event Date 08/23/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted late due to a retrospective review of complaints for the qdot micro products.Biosense webster¿s investigation determined that upon approval of qdot in the united states on november 23, 2022, the electronic complaints system was not updated and therefore medical device reports were not submitted in a timely manner.Through biosense webster¿s investigation it was determined that this was an isolated case.An internal action was opened to address this issue.This complaint is from a literature source.The following literature cite has been reviewed: chu g, calvert p, sidhu b, mavilakandy a, kotb a, tovmassian l, kozhuharov n, biermé c, denham n, pius c, o'brien j, ding wy, luther v, snowdon rl, ng ga, gupta d.Patient experience of very high power short duration radiofrequency ablation for atrial fibrillation under mild conscious sedation.J interv card electrophysiol.2023 mar;66(2):445-453.Doi: 10.1007/s10840-022-01351-5.Epub 2022 aug 23.Pmid: 35997848; pmcid: pmc9396586.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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

This complaint is from a literature source.The following literature cite has been reviewed: chu g, calvert p, sidhu b, mavilakandy a, kotb a, tovmassian l, kozhuharov n, biermé c, denham n, pius c, o'brien j, ding wy, luther v, snowdon rl, ng ga, gupta d.Patient experience of very high power short duration radiofrequency ablation for atrial fibrillation under mild conscious sedation.J interv card electrophysiol.2023 mar;66(2):445-453.Doi: 10.1007/s10840-022-01351-5.Epub 2022 aug 23.Pmid: 35997848; pmcid: pmc9396586.Objective/methods/study data: lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: qdot micro ablation catheter other biosense webster devices that were also used in this study: n/a non-biosense webster devices that were also used in this study: arctic front advance pro cryo ablation catheter (medtronic); polar x cryo ablation catheter (boston scientifc) exact quantities of products cannot be accurately determined as patients can experience more than adverse event and the data is summarized.Adverse event(s) and provided interventions possibly associated with unk_qdot micro qty 2 transient signs or symptoms of one global amnesia and one dysphagia (transient ischemic attack) managed conservatively (minor injury) and resolved.Qty 2 (cardiac tamponade) that required pericardiocentesis (recognized procedural complication) that resolved.Qty 1 chest infection (infection) managed with antibiotic therapy (minor injury) that resolved.

• Brand Name: UNK_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: 17612686
• MDR Text Key: 321848016
• Report Number: 2029046-2023-01854
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_QDOT MICRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ARCTIC FRONT ADV PRO CRYO ABLATION CATH(MEDTRONIC); OLAR X CRYO ABLATION CATHETER (BOSTON SCIENTIFC)
• Patient Outcome(s): Required Intervention; Life Threatening