MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, F-J CURVE, C3, SPLIT HANDLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139504

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Nerve Damage (1979); Paralysis (1997)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure using a qdot-micro, bi-directional, f-j curve, c3, split handle (unknown lot).After ablation, the patient experienced phrenic nerve palsy that required prolonged hospitalization.Female patient experienced phrenic nerve palsy and hospitalization for 7 days after a carto af ablation using qdot and octaray catheters.No further information is available at the time of this report.

Manufacturer Narrative

On 18-oct-2023, bwi received additional information regarding the event.The physician's opinion on the cause of this adverse event (right phrenic nerve palsy) is rf (radiofrequency) ablation (qdot catheter at 50w) for pulmonary vein isolation.Conservative intervention for the phrenic nerve palsy was provided.Patient has recovered--however, the patient was not fully recovered by discharged date.A reassessment was scheduled to take place a few weeks post discharge.Patient required extended hospitalization for 8 days instead of the originally planned one-day stay.The prolonged stay was for significant respiratory symptoms due to hypoxia from phrenic nerve palsy.Patient had cxr (chest xray) and chest uss (ultrasound scan) confirming right phrenic nerve palsy.As a result, the e0123 (nerve damage) health effect - clinical code in h6 has been removed.And e012202 (paralysis) has been added.Additionally, the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Udi : related data quality updates only.Correction to the initial mdr, incomplete udi was provided without an explanation.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: QDOT-MICRO, BI-DIRECTIONAL, F-J CURVE, C3, SPLIT HANDLE
• 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: 17943264
• MDR Text Key: 325764946
• Report Number: 2029046-2023-02328
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835016741
• UDI-Public: 10846835016741
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2023

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: D139504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 10/18/2023; 07/11/2024
• Supplement Dates FDA Received: 11/14/2023; 07/19/2024
• 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: CARTO 3 SYSTEM; CARTO VISITAG MODULE; NGEN GENERATOR; OCTARAY CATHETER; THERMOCOOL SMARTTOUCH
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Sex: Female