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

Model Number R7F282CT

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: (1) mfr # 2029046-2020-00526 for product code r7f282ct (decanav electrophysiology catheter).(2) mfr # 2029046-2020-00527 for product code r7f282ct (decanav electrophysiology catheter).

Event Description

It was reported that a patient underwent an ablation procedure with two (2) decanav electrophysiology catheters and a loss of all signals on both catheters occurred.It was reported that during a pulmonary vein isolation (pvi) ablation procedure, they had noise on the signals of the decanav electrophysiology catheter¿s electrodes 7-8 occurred and then electrodes 5-6 being displayed on the carto 3 system and the ep recording systems.Shortly after the signal loss was observed on all the ecg channels including body surface (bs) signals.The following troubleshooting has been performed: detaching all cable from the patient interface unit (piu) and restarting it.After that the cables were attached one-by-one, revealing the source of the issue coming from either the decanav electrophysiology catheter cable or the decanav electrophysiology catheter.First the cable was replaced with a new one (ineffective maneuver), then a new decanav electrophysiology catheter has been attached (from the same lot as the first one, lot:30315596m), which did not solve the issue.Even with the catheter outside the patient the signal interference persisted.The 2nd decanav electrophysiology catheter was replaced with a conventional decapolar catheter, and the issue was resolved.On 3/16/2020, additional information was received which indicated that no ecg signal was available for the physician to monitor the patient¿s heart rhythm during the signal loss issue, the anesthesia monitor was also affected by the signal interference.No patient consequences were reported.This event was originally considered non-reportable, however, bwi became aware of additional information on 3/16/2020 and reassessed this complaint as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a decanav electrophysiology catheters and a loss of all signals occurred.It was reported that during a pulmonary vein isolation (pvi) ablation procedure, they had noise on the signals of the decanav electrophysiology catheter¿s electrodes displayed on the carto 3 system and the ep recording systems.Shortly after the signal loss was observed on all the ecg channels including body surface (bs) signals.No patient consequences were reported.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions.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 and internal action related to the reported complaint condition were identified.The customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

The bwi product analysis lab received the complaint device for evaluation.Initial visual analysis observed there was no visual damage or anomalies.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: DECANAV ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9941770
• MDR Text Key: 202078795
• Report Number: 2029046-2020-00528
• 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,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30315596M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7FR DECAN,11P,F,2.4MMLE,282MM,; CARTO 3 SYSTEM; EP RECORDING SYSTEM; UNKNOWN DECAPOLAR CATHETER