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

Model Number R7F282CT

Device Problem Electrical Shorting (2926)

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

Event Date 06/08/2022

Event Type  malfunction  

Manufacturer Narrative

Device investigation details: according to pictures provided by the customer, error 7 "leakage current detected" was observed on the carto3 screen. also, noise was observed on the carto3 screen.A manufacturing record evaluation was performed for the finished device 30743330m number, and no internal actions related to the reported complaint were identified.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 an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter.Current leakage error occurred causing signal loss on all ecg (bs + ic) channels.It was reported that during procedure, leakage current was detected on piu rl input.A second catheter was used to complete the operation.There was no adverse event reported on patient.(error code:7) the current leakage error was displayed due to a signal noise / signal loss issue.The signal interference (noise/loss) was observed on all ecg (bs + ic) channels.The signal interference (noise/loss) was observed on carto® and recording system.No ecg/ekg signal was available for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was inside the patient¿s body.For the moment the device could not be shipped back due to covid-19.Current leakage is not mdr-reportable.No ecg on all channels is mdr-reportable.

Manufacturer Narrative

On 22-jul-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: visual analysis revealed no damage or anomalies on the device.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no magnetic issues were observed.An electrical test was performed, and an open circuit was found on the tip area.Current leakage was observed during the electrical test, the device was observed with the microscope and corrosion was observed, the root cause of the corrosion cannot be determined.The root cause of the current leakage could be related to the corrosion observed.A manufacturing record evaluation was performed for the finished device 30743330m number, and no internal action was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.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 ELECTROPHYSIOLOGY 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
• 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: 14890294
• MDR Text Key: 301991852
• Report Number: 2029046-2022-01503
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2022

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 Expiration Date: 03/03/2023
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30743330M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1