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

Catalog Number D139402

Device Problems Insufficient Cooling (1130); Contamination /Decontamination Problem (2895)

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

Event Date 07/12/2023

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 in the pebax with exposure to internal components.Initially it was reported that after advancing the catheter to the ablation position, no energy could be delivered.We received the message "temperature gradient too high" on the ngen.The catheter was then removed from the patient and the tip was inspected.It was found that blood had entered the catheter tip, which probably disturbed the thermocouple sensors.The catheter was replaced, after which no more problems occurred and the procedure could be completed without any consequences for the patient.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 27-nov-2023, observed a hole in the pebax with exposure to internal components and traces of blood.This event was originally considered non-reportable, however, bwi became aware of a hole in the pebax with exposure to internal components on 27-nov-2023 and have assessed this returned condition as reportable.

Manufacturer Narrative

The device evaluation was completed on 27-nov-2023.The device was returned to biosense webster (bwi) for evaluation.The returned device's visual inspection, temperature impedance, and patency tests were performed following bwi procedures.Visual analysis revealed a hole in the pebax with exposure to internal components and traces of blood.The root cause of the damage could be related to improper handling; however, this cannot be conclusively determined.The device underwent temperature and impedance tests, passing without any problems.A patency test revealed an occlusion of the irrigation holes with saline solution; which could be related to the procedure.However, the damage on the pebax could be related to the temperature issue reported.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: when radio frequency (rf) current is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned of coagulum if present.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.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: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿blood had entered the catheter tip¿ and the "message of temperature gradient too high" and biosense webster inc.Analysis finding of the ¿hole in the pebax with exposure to internal components and traces of blood¿.Investigation findings: operational problem identified (c13)/ investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the biosense webster inc.Analysis finding of the ¿foreign material blocking the irrigation holes with saline solution¿.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: 18400583
• MDR Text Key: 332404647
• Report Number: 2029046-2023-03044
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017076
• UDI-Public: 10846835017076
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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: 31061637L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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_NGEN RF GENERATOR