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

Catalog Number	D139504
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and magnetic test of the returned device were performed.Visual analysis revealed reddish brown material inside the pebax and a separation between the pebax and the electrode section.The device was connected to the carto 3 system and it was recognized and visualized correctly.No magnetic issues or errors were observed.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 visualization issue reported by the customer; therefore, the foreign material and visualization issue reported were confirmed.The root cause of the pebax damage is traced to the manufacturing process.An internal action was created for further investigation of the force sensor sleeve insolation to prevent fluids to get inside into the device.The instructions for use (ifu) contain the following recommendations: do not scrub or twist the tip electrode as damage to the tip electrode bond may occur and loosen the tip electrode, or damage may also occur to the contact force sensor and affect measurement accuracy.In addition, in order to prevent damage to the catheter tip, verify compatibility between the sheath and catheter, advance the catheter through the sheath prior to insertion.Any sheath < 8.5 f is contraindicated.The carto® 3 system instructions for use (ifu) contain the following information: verify that metal objects have not been introduced into the field.Verify that the fluoroscope tube is not too close to the location pad.If it is, raise the table, or change the fluoroscope position so that the tube is farther away from the location pad.Verify that the fluoroscopy detector is not too close to patient's chest.If it is, raise its position.Verify that the catheter's handle is at least 30 cm from the location pad.Replace the cable or the catheter.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 separation between the pebax and electrode section it was initially reported by the customer that the qdot catheter had a visualization issue during the procedure.The caller stated the qdot catheter had jumped/moved about a foot on the carto 3 system.The caller stated there were no errors displayed.The caller stated the catheter cable was replaced without resolution.The caller stated the catheter was replaced, the issue resolved.The procedure was continued.There was no patient consequence.The customer's reported visualization 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 14-jul-2025, the bwi pal revealed that a visual inspection of the returned device found a reddish-brown material inside the pebax and a separation between the pebax and the electrode section.These findings were reviewed and assessed the issue of a ¿separation¿ in the pebax are as an mdr reportable malfunction since the integrity of the device has been compromised.

• Brand Name: QDOT MICRO
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22745918
• Report Number: 2029046-2025-02622
• Device Sequence Number: 9122429
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: (01)10846835016741(11)250131(17)280130(10)31552756L
• 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: D139504
• Device Lot Number: 31552756L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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: CARTO 3 SYSTEM.
• Patient Sex: Unknown