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

Catalog Number D139505

Device Problems Insufficient Cooling (1130); Failure to Sense (1559); Device Contamination with Body Fluid (2317)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on (b)(6) 2023.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and functional tests of the returned device were performed following bwi procedures.Visual analysis revealed a hole on the pebax leaving internal parts exposed.According to the pictures provided by decontamination site, char was observed on the tip; however, during the analysis in the lab, the device was visually inspected and it was found in good condition.No char attached to the device's tip was observed.The device was connected to the carto 3 system and no errors or issues were observed.A screening test was performed and the device passed the test.Then, the temperature and impedance test was performed and no issues were observed.A patency test was performed and no irrigation issues were observed.The root cause of the damage on the pebax could be related to the handling since in the process there are control inspection points to avoid this kind of issue; however, this cannot be conclusively determined.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The char issue was confirmed; however, the magnetic and high temperature issues reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿magnetic sensor error¿ and ¿high temperature¿ issues.Investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: no problem detected (d14) / component code: sleeve (g04115) were selected as related to the biosense webster inc.Analysis finding of a ¿hole on pebax leaving internal parts exposed¿.Investigation findings: contamination of environment by device (c1503) / investigation conclusions: cause not established (d15) / component code: cautery tip (g01002) were selected as related to the customer¿s reported ¿char¿ issue.Manufacturer's reference number: (b)(4).

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 leaving internal parts exposed.During the procedure, when they were ablating, they were receiving temperature spike readings on the smartablate generator.To troubleshoot, the catheter was removed from the patient's body and they discovered char all over the catheter.Upon replacement of the catheter, they received error 105: magnetic sensor error.The catheter was replaced a second time and the issue seemed to be resolved.They were able to successfully ablate; however, upon finishing ablation and removing the catheter they noticed char all over this catheter as well.All three catheters used were from the same lot.There was no patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2023, there was a hole on the pebax leaving internal parts exposed observed.This event was originally considered non-reportable, however, bwi became aware of a hole on the pebax leaving internal parts exposed on (b)(6) 2023 and have assessed this returned condition as reportable.

• 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: 18315042
• MDR Text Key: 330944217
• Report Number: 2029046-2023-02928
• 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
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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: 31043662L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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: QDOT MICRO, BI, TC, D-F; QDOT MICRO, BI, TC, D-F; UNK_SMARTABLATE GENERATOR