MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number BN7TCDF4L

Device Problems Break (1069); Image Orientation Incorrect (1305)

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

Event Date 08/02/2021

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 an unknown patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter.The tip was off.The tip of the catheter was reversed.The catheter was replaced and the issue was resolved.The case continued.The damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The tip localization was off.The catheter was not pre-shaped.The sheath used was a short 9f cook.The case continued and ended successfully.No patient consequences were reported.The broken tip is mdr-reportable.

Manufacturer Narrative

On 21-sep-2021, the product investigation was completed as the complaint device was not returned.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 30501901m 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On (b)(6)-2021, the product was returned to biosense webster for evaluation.The product investigation was subsequently completed.It was reported that an unknown patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter.The tip was off.The tip of the catheter was reversed.The catheter was replaced and the issue was resolved.The case continued.The damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The tip localization was off.The catheter was not pre-shaped.The sheath used was a short 9f cook.The case continued and ended successfully.No patient consequences were reported.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the ez steer catheter.Carto was testing and the catheter was properly visualized and no errors were observed.A manufacturing record evaluation was performed for the finished device 30501901m number, and no internal action related to the complaint was found during the review.No magnetic issues were verified during analysis, the instructions for use contain the following warning stated in the carto 3 system manual: the magnetic sensor of the catheter is disconnected, if the problem persists, replace the catheter cable or the catheter.The event described could not be confirmed as the device performed without any magnetic 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 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: EZ STEER NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Type of Device: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12357506
• MDR Text Key: 267831437
• Report Number: 2029046-2021-01375
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (y/n): N
• PMA/PMN Number: P990025/S12
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: BN7TCDF4L
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 30501901M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SHORT 9F COOK SHEATH; CARTO 3 SYSTEM; SHORT 9F COOK SHEATH