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

Catalog Number D139402

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib)procedure with a qdot micro¿ catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax surface with reddish material inside.Initially, it was reported that the force readings would go very high when going on ablation on the carto 3 system.Before going on ablation, the force readings were at 2-3 grams and when going on ablation, the force would shoot up to 85-90 grams.When the catheter was replaced, the issue resolved.No adverse patient consequence was reported.The force issue was assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 10-jan-2024, there was a hole on the pebax and reddish material was inside of it.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 10-jan-2024.

Manufacturer Narrative

The device was returned to biosense webster for evaluation.Visual inspection and functionality test of the returned device were performed following bwi procedures.Visual inspection was performed, and a hole was observed on the pebax surface with reddish material inside.The damage on the pebax surface could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.The device was connected to the carto 3 system and the device was recognized correctly; however, the message hi appeared on the carto 3 screen.The device was dissected, and an internal pcb (printed circuit board) issue was found, causing the issue.However, the reddish material inside the pebax and pcb issues could be related to the force issue reported by the customer.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.A manufacturing record evaluation was performed for the finished device batch number 31148191l, and no internal actions were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the hole on the pebax.Investigation findings: incompatible component/ accessory (c0402) / investigation conclusions: cause traced to component failure (d02) / component code: circuit board (g02005) were selected as related to the pcb issue found.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).

• 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: 18628466
• MDR Text Key: 334389880
• Report Number: 2029046-2024-00377
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017076
• UDI-Public: 10846835017076
• 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
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139402
• Device Lot Number: 31148191L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• 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: UNK_CARTO 3; UNK_NGEN RF GENERATOR