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

Catalog Number D139505

Device Problems Device Alarm System (1012); Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)

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

Event Date 01/09/2024

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.There was a bubble error.During flush, the physician in charge checked the tip of the catheter and found a pool of blood in the clear part of the tip.Attempted to ablate as it was, but contact force (cf) suddenly went into high contact.The behavior was abnormal and was resolved by catheter replacement to another new one.No error messages on the carto 3 side.The procedure was completed without any problems.No patient consequence.Timing was when inserting the qdot micro catheter into the left atrium.Ngen generator used.No other generator was used.Sheath used was the nihon kohden agilis, g408319, m-curve 8.5 fr sheath.Additional information was received.No difficulty experienced while maneuvering the catheter or during the withdrawal.No damage, visually.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 06-mar-2024 there was a hole observed on the pebax surface with reddish material inside of it.The event was originally considered non-reportable, however, bwi became aware of a hole on the pebax surface on 06-mar-2024 and have assessed this returned condition as reportable.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6) the bwi product analysis lab received the device for evaluation on 20-feb-2024.The device evaluation was completed on 06-mar-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual inspection was performed and a hole was observed on the pebax's surface with reddish material inside it.The magnetic and force features were tested and errors 105 and 106 were displayed on the screen, due to the damage on the pebax's surface.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The reddish material inside the pebax could be related to the issues reported by the customer; therefore, the customer complaint was confirmed.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.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.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: 18995559
• MDR Text Key: 338876039
• Report Number: 2029046-2024-01038
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 31172640L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2023
• 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: NIHON KOHDEN AGILIS 8.5 FR SHEATH; UNK_CARTO 3; UNK_NGEN RF GENERATOR