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

Model Number R7F282CT

Device Problems Failure to Sense (1559); Material Separation (1562)

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

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30468152m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a decanav electrophysiology catheter and internal components were exposed on the shaft of the catheter.During the procedure, there was a "severe magnetic distortion" error displayed on the carto 3 system for the decanav electrophysiology catheter.They disconnected the decanav electrophysiology catheter from the ref/deca port on the patient interface unit and the error had resolved.The catheter cable was replaced without resolution.The decanav electrophysiology catheter was replaced and the issue resolved.It was reported that when replacing the first decanav electrophysiology catheter , it was noticed that there was damage on the shaft of the catheter as there was a metal piece exposed on the shaft.The procedure continued.No patient consequences were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The magnetic sensor error was assessed as not mdr reportable.The incidence of magnetic sensor error was easily detectable by the user.The catheter was not inoperable since it could not be visualized on the carto 3 system.Therefore, the user would have to replace the catheter.The potential risk that it could cause or contribute to a serious injury or death was remote.The internal components exposed on the shaft of the catheter was assessed as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a decanav electrophysiology catheter and internal components were exposed on the shaft of the catheter.During the procedure, there was a "severe magnetic distortion" error displayed on the carto 3 system for the decanav electrophysiology catheter.The decanav electrophysiology catheter was replaced and the issue resolved.It was reported that when replacing the first decanav electrophysiology catheter , it was noticed that there was damage on the shaft of the catheter as there was a metal piece exposed on the shaft.The procedure continued.No patient consequences were reported.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation on 3/22/2021.The device evaluation has been completed.Bwi conducted a general inspection through the visual inspection and carto 3 testing.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the decanav electrophysiology catheter.The shaft was found in normal/good conditions without damage nor internal parts exposed.The magnetic sensor test was performed, in accordance with bwi procedures.The carto 3 system displayed error 105.As such, a failure analysis was performed finding an internal pc board issue.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The product instructions for use (ifu) contain the following recommendations, which was following by the physician: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿internal components exposed¿.Investigation findings: incompatible component/ accessory (c0402) / investigation conclusions: cause traced to component failure (d02) / component code: circuit board (g02005) were selected as related to the customer¿s reported magnetic sensor errors.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-000846029.

• 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: 11377078
• MDR Text Key: 233579734
• Report Number: 2029046-2021-00226
• 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
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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: 11/19/2021
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30468152M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND DECANAV CATHETER; UNK_CARTO 3; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND DECANAV CATHETER; UNK_CARTO 3