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 Paralysis (1997)

Event Date 10/04/2023

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).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 31078575l 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

It was reported that a patient underwent a cardiac ablation procedure using qdot micro catheter.The patient experienced diaphragmatic nerve paralysis.First (before the start of ablation) without patient consequence, catheter sensor error occurred on ngen screen.The temperature was displayed, but the bullseye was not displayed.The issue was resolved by replacing qdot micro catheter (lot #: 31105503l) to another new one (qdot micro catheter / lot #: 31078575l).The issue was resolved by replacing qdot micro catheter to another new one.During the procedure with the replacement qdot micro catheter, patient experienced diaphragmatic nerve paralysis.Physician assessment of the health hazard was non-serious (moderate/minor).The physician commented that he/she believed the cause was the failure to properly check the location of the diaphragmatic nerve.The site near the phrenic nerve was ablated, but the location of the phrenic nerve was confirmed in advance.Partial reactions were present and the issue seemed to be unavoidable.No additional treatment for the diaphragmatic nerve paralysis.Was performed.Medical history includes icd implantation.Additional information received.The physician commented that the adverse event occurred due to insufficient confirmation of the location of phrenic nerve.No intervention was required to treat the adverse event.The catheter sensor error was assessed as not mdr reportable.The adverse event was assessed as mdr reportable.

Manufacturer Narrative

Additional information was received on 01-nov-2023.Patient fully recovered.The patient did not require extended hospitalization.In addition, the physician information was provided.Therefore, updated e.Initial reporter section.Also, originally reported the concomitant product of unk_ngen rf generator.Additional information provided the generator product information.Therefore, updated d10.Concomitant medical products and therapy dates section.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
• 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: 18031394
• MDR Text Key: 326869544
• Report Number: 2029046-2023-02478
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• 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: 31078575L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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: NGEN RF GENERATOR, JAPAN; QDOT MICRO, BI, TC, D-F; UNK_CARTO 3; UNK_NGEN RF GENERATOR
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 60 KG