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

Catalog Number D139505

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

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.Biosense webster manufacturer's reference number (b)(4) has three reports: (1) mfr # 2029046-2023-02955 for product code d139505 (qdot micro¿ catheter).(2) mfr # 2029046-2023-02956 for product code d160903 (octaray mapping catheter).(3) mfr # 2029046-2023-02957 for product code d138502 (carto vizigo¿ 8.5f bi-directional.Guiding sheath ¿ medium).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) - persistent ablation procedure with a qdot micro¿ catheter, octaray mapping catheter, and a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a plastic film was found on the tip of the catheters.It was reported that a plastic film was discovered on the tip of the qdot catheter after it was advanced through the vizigo sheath.The octaray catheter was taken out of the body and was discovered to have a plastic film on the tip.The film was taken off both catheters and both catheters were inserted in the body.The procedure continued without further issues.The vizigo sheath is suspected to have shed plastic on both catheters.

Manufacturer Narrative

On 21-dec-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) was performed for the finished device 31153011l number, and no internal action related to the complaint was found during the review.Based on the completed mre, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with appropriate information.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has three reports: (1) mfr # 2029046-2023-02955 for product code d139505 (qdot micro¿ catheter).(2) mfr # 2029046-2023-02956 for product code d160903 (octaray mapping catheter).(3) mfr # 2029046-2023-02957 for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium).

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 08-feb-2024.The device evaluation was completed on 20-feb-2024.It was reported that a patient underwent an atrial fibrillation (afib) - persistent ablation procedure with a qdot micro¿ catheter, octaray mapping catheter, and a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a plastic film was found on the tip of the catheters.It was reported that a plastic film was discovered on the tip of the qdot catheter after it was advanced through the vizigo sheath.The octaray catheter was taken out of the body and was discovered to have a plastic film on the tip.The film was taken off both catheters and both catheters were inserted in the body.The procedure continued without further issues.The vizigo sheath is suspected to have shed plastic on both catheters.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned device revealed no plastic film material in the tip.No other damage nor anomalies were observed.A manufacturing record evaluation was performed for the finished device 31153011l number, and no internal action related to the complaint was found during the review.The issue reported by the customer could not be confirmed during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has three reports: (1) mfr # 2029046-2023-02955 for product code d139505 (qdot micro¿ catheter).(2) mfr # 2029046-2023-02956 for product code d160903 (octaray mapping catheter).(3) mfr # 2029046-2023-02957 for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium).

• Brand Name: QDOT MICRO¿ CATHETER
• 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: 18326006
• MDR Text Key: 330494184
• Report Number: 2029046-2023-02955
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 31153011L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/21/2023; 02/08/2024
• Supplement Dates FDA Received: 01/18/2024; 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• 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: 8.5F SHEATH WITH CURVE VIZ MDC.; OCTA,LNG,48P,3-3-3-3-3,D-CURVE.