MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, UNI-DIRECTIONAL, D CURVE, C3, SPLIT HANDLE; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Catalog Number D139401

Device Problems Insufficient Cooling (1130); Material Puncture/Hole (1504)

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

Event Date 05/03/2022

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual analysis revealed reddish material inside the pebax on the device.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.A cool flow pump and pressure gage test was performed, and the device was not irrigating correctly.An irrigation issue was observed, the device was dissected and it was observed that the irrigation tube had a bent.A manufacturing record evaluation was performed for the finished device 30739318l number, and no internal actions related to the complaint were found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

A patient underwent an ablation procedure with a qdot-micro, uni-directional, d curve, c3, split handle for which biosense webster¿s product analysis lab identified reddish material inside the pebax.It was initially reported by the customer that after ablation started with qmode+/ngen ablation terminated after a few seconds displaying ¿temperature slope too high¿.No other error displayed on carto or ngen.Changing cables and rebooting the system did not solve the issue.After changing the catheter ablation was possible and system was working properly.No patient consequences were reported.High temperature cut-off exceeded is not mdr-reportable.Foreign material inside the pebax/external damage to the pebax is mdr-reportable.

• Brand Name: QDOT-MICRO, UNI-DIRECTIONAL, D CURVE, C3, SPLIT HANDLE
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15299629
• MDR Text Key: 305531112
• Report Number: 2029046-2022-01994
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2022

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 Catalogue Number: D139401
• Device Lot Number: 30739318L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• 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