MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number R7F282CT

Device Problems Signal Artifact/Noise (1036); Failure to Sense (1559)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that a patient underwent a procedure for a persistent atrial fibrillation (afib).The devices that were used in this procedure is the decanav catheter.The device was not able to be used as there was an error that occurred.There was also magnetic distortion.It was mentioned that it was impossible to continue and interpret any signal.As a result, the cable was changed, and ruled out any fluoroscopy issues.There were no changes.Finally, the catheter was replaced, and it worked.The surgeon did not have any good electrocardiogram (ecg) signal to read.The didn't try to obtain a signal from the defibrillator.It was also noted that during the signal interference, the affected catheter was inside the patient.The magnetic sensor error is not mdr-reportable.The bad/no ecg on all channels is mdr-reportable (due to lack of monitoring of cardiac rhythm).

Manufacturer Narrative

On 30-jul-2021, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.It was reported that a patient underwent a procedure for a persistent atrial fibrillation (afib).The devices that were used in this procedure is the decanav catheter.The device was not able to be used as there was an error that occurred.There was also magnetic distortion.It was mentioned that it was impossible to continue and interpret any signal.As a result, the cable was changed, and ruled out any fluoroscopy issues.There were no changes.Finally, the catheter was replaced, and it worked.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, an electrical and carto 3 evaluation of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the decanav catheter.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.A manufacturing record evaluation was performed for the finished device 30545908m number, and no internal actions related to the reported complaint condition were identified.Also, carto 3 test was performed, in accordance with bwi procedures.The product was working correctly: it was properly recognized and visualized.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the as the device performed without any electrical issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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: DECANAV CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12140205
• MDR Text Key: 261492628
• Report Number: 2029046-2021-01077
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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: 04/12/2022
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30545908M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1