MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number BNI35DFH

Device Problem Failure to Sense (1559)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).As reported, the event date is unknown.As a result, the 1st day of the year has been entered as the event date under b3.Date of event.The investigation was completed on 17-aug-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed that a metal braid was exposed on the shaft.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no magnetic issues were observed.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 ¿error 105¿ issue.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the biosense webster inc.Analysis finding of the ¿metal braid exposed on the shaft¿ issue.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 an atrial fibrillation (afib) ablation procedure with a thermocool® sf nav bi-directional catheter for which biosense webster¿s product analysis lab (pal) identified metal braid exposed on the shaft.Initially after connecting the catheter to the patient interface unit (piu) for afib-ablation, the error 105 occurred.Troubleshooting was done.Cable was changed, at least the catheter no1 and no2 was changed.The procedure started and finished successfully with the catheter.It was unknown if the surgery was delayed due to the reported event.It was unknown if the procedure was successfully completed.There was no patient consequence.The error 105 was assessed as non mdr reportable.The incidence of magnetic sensor error was easy detectable by the user.The catheter was inoperable since it cannot be visualized on the carto system.The user will have to replace the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 17-aug-2023, observed metal braid exposed on the shaft.Clarification was requested on the returned catheter condition and no additional information to clarify the returned condition was provided.The returned condition of the metal braid exposed on the shaft was assessed as mdr reportable.The awareness date for this reportable lab finding was 17-aug-2023.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17747542
• MDR Text Key: 323629083
• Report Number: 2029046-2023-02075
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835003215
• UDI-Public: 10846835003215
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2023

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 Catalogue Number: BNI35DFH
• Device Lot Number: 30770872L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• 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
• Treatment: THERMOCOOL SF CARTOXP,D-F,TC; UNK CABLE; UNK_CARTO 3