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

Catalog Number	D139403
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and magnetic sensor functionality test evaluation of the returned device was performed following bwi procedures.Visual analysis revealed a reddish material and a hole in the surface of the pebax.The device was connected to the carto 3 system and no magnetic sensor error was displayed.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 magnetic issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The catheter instructions for use state: do not scrub or twist the distal tip electrode during cleaning.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot micro for which biosense webster¿s product analysis lab (pal) identified a reddish material and a hole in the surface of the pebax.It was initially reported by the customer that a map magnetic distortion error displayed when physician would come on ablation and the catheter would jump outside of the fam (error number unknown by caller).Caller stated that they shifted around the patient table without resolution.The cable was replaced without resolution.The catheter was replaced and the issue resolved.The procedure continued.The customer's reported magnetic sensor issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 18-jul-2024, the bwi pal revealed that a visual inspection of the returned device found a hole in the pebax and a reddish material inside the pebax.These findings were reviewed and assessed the issue of a ¿hole¿ in the pebax as an mdr reportable malfunction since the integrity of the device has been compromised.

• Brand Name: QDOT MICRO, UNI, TC, J
• Common Device Name: 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: 19984488
• Report Number: 2029046-2024-02682
• Device Sequence Number: 4343277
• Product Code: OAE
• UDI-Device Identifier: 10846835017106
• UDI-Public: (01)10846835017106(11)240328(17)270327(10)31280147L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: D139403
• Device Lot Number: 31280147L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN NGEN SYSTEM.
• Patient Sex: Unknown