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 Problem Patient Device Interaction Problem (4001)

Patient Problem Hematoma (1884)

Event Date 02/08/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: khalid bin waleed and others, stridor and dyspnoea after ablation for atrial fibrillation, ep europace, volume 25, issue 1, january 2023, page 129, https://doi.Org/10.1093/europace/euac166.Case:a 74-year-old female underwent redo catheter ablation for symptomatic atrial fibrillation.Transeptal puncture was performed without difficulty.The pulmonary veins had remained isolated, so radiofrequency energy was applied at the left atrial roof and posterior wall, and cavotricuspid isthmus by qdot® catheter (biosense webster) using the qmode plus protocol without immediate complication.Approximately 10 h post-ablation, the patient reported a foreign-body sensation in the throat and then progressive dyspnoea with stridor.Chest x-ray showed widening of the upper mediastinum (panel a).Computed tomography (ct) at 24 h post-ablation showed a 6 × 3.5 cm haematoma extending 12 cm from the mediastinum into the neck and compressing surrounding structures including displacement of the trachea (panel b).The patient was intubated and ventilated without difficulty.Repeated ct on day 3 showed shrinkage of the haematoma and reduced tracheal compression.The patient was extubated; her subsequent recovery was uneventful despite the resumption of anticoagulation at 1 week.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: n/a.Adverse event(s) and provided interventions possibly associated with unk_qdot micro: qty 1 haematoma (hematoma) treated by intubation (prolonged hospitalization).

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.The file containing the literature article is too large to attach.This complaint is from a literature source.The following literature cite has been reviewed: khalid bin waleed and others, stridor and dyspnoea after ablation for atrial fibrillation, ep europace, volume 25, issue 1, january 2023, page 129, https://doi.Org/10.1093/europace/euac16.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).

• 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: 17624019
• MDR Text Key: 321955140
• Report Number: 2029046-2023-01896
• 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
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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: 05/25/2023
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female