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

Catalog Number D139505

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.It was initially reported by the customer there was a force sensor error and blood in the tip of catheter.No consequences for the patient reported.To procedure was completed by the physician when they used another product the same type.The customer¿s reported issue of sensor error is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 23-nov-2023, the bwi pal revealed that a visual inspection of the returned device found a hole in the pebax.This finding was reviewed and assessed the issue of a ¿hole¿ in the pebax as an mdr reportable malfunction since the integrity of the device has been compromised.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and screening test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed a hole in the pebax and foreign reddish material was observed inside it.A screening test was performed, and the device was visualized and recognized correctly; no force issues were observed, and since the sensor values were found within specifications, the event described by the customer could be related to the reddish material inside the pebax, however, the root cause of the damage on the pebax could not be determined; it was concluded that it occurred outside the bwi manufacturing facilities.A manufacturing record evaluation was performed for the finished device 31055915l, and no internal action was found during the review.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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.Manufacturer's ref.# (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: 18344918
• MDR Text Key: 331087275
• Report Number: 2029046-2023-02989
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Other
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• 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: 31055915L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2023
• 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