MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO; 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 Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on 21-dec-2023.The qdot micro device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material and a hole in the pebax.The magnetic and force features were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.The blood found inside the pebax area may contribute to the force issue reported.A manufacturing record evaluation was performed and no internal action was found during the review.The issue reported by the customer was confirmed.The instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.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).

Event Description

It was reported that a patient underwent an ablation procedure with a qdot micro which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.The system showed a "streaming error contact force" and could not show any force value.The error stayed after changing the cable.After changing the catheter, the error was gone immediately.The catheter was exchanged before any ablation was conducted.No patient consequence.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 21-dec-2023, reddish material and a hole in the pebax was observed.This event was originally considered non-reportable, however, bwi became aware of a hole in the pebax on 21-dec-2023 and have assessed this returned condition as reportable.

Manufacturer Narrative

Additional information was received on 22-jan-2024.The actual user was unknown.Therefore, provided contact details for the director, univ.Hospital clinic for rhythmology.Therefore, updated section "e.Initial reporter".Initial reporter title: prof.Dr.Initial reporter phone: (b)(6) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: 18545281
• MDR Text Key: 333494443
• Report Number: 2029046-2024-00239
• 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,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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: 31081184L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2023
• 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 CABLE; UNK_NGEN RF GENERATOR