MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, UNI-DIRECTIONAL, D CURVE, C3, SPLIT HANDLE; SIMILAR DEVICE D134701, PMA # P030031/S078

Catalog Number D139401

Device Problem Failure to Sense (1559)

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

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and functional test of the returned device.Visual analysis of the returned sample revealed reddish material and a hole in the pebax, internal parts are exposed in the qdot device.The magnetic sensor test was performed, in accordance with bwi procedures.Carto 3 displayed error 106.The handle was dissected and it was found an open circuit in this area.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations, which were followed by the physician: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.Note: the ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch® sf uni-directional navigation catheter approved under p030031/s078.Initial reporter phone: (b)(6).(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

A patient underwent a cardiac ablation procedure with a qdot-micro, uni-directional, d curve, c3, split handle for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.It was initially reported by the customer that an error 106: force sensor error occurrred.After changing the cable, a new catheter solved the issue.There was no patient consequence.The customer¿s reported sensor issue is not mdr reportable since the warning functioned as intended.On 24-feb-2021, pal revealed that visual inspection of the returned device found a reddish material and a hole in the pebax.This finding has been assessed as an mdr reportable malfunction since the integrity of the device has been compromised.

• Brand Name: QDOT-MICRO, UNI-DIRECTIONAL, D CURVE, C3, SPLIT HANDLE
• Type of Device: SIMILAR DEVICE D134701, PMA # P030031/S078
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13875975
• MDR Text Key: 290454713
• Report Number: 2029046-2022-00588
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• Device Catalogue Number: D139401
• Device Lot Number: 30481782L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: QDOT MICRO, UNI, TC , D