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

Catalog Number D134805

Device Problem Failure to Sense (1559)

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

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.The returned device's visual inspection and screening test were performed following bwi procedures.Visual analysis revealed a hole in the pebax with dry reddish material inside it.The root cause of the condition could be related to the handling during procedure since in there are control inspection points in the process to avoid these issues.The device was connected to the carto 3 system and was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit on the tip area.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.Biosense webster's quality process ensures all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the issue of hole in the pebax.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer's reported force sensor error.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an right atrial flutter (r-afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster¿s product analysis lab (pal) identified a hole in the pebax area.It was initially reported that the carto 3 system displayed a force sensor error (error code 106) about 30 minutes into the procedure.The cable was replaced without resolution.The catheter was replaced and the issue was resolved.The procedure was continued.There was no patient consequence.The customer¿s reported force sensor error is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On (b)(6) 2023, the bwi pal revealed that a visual inspection of the returned device found a hole in the pebax with dry reddish material inside it.These findings were reviewed and assessed as mdr reportable for malfunction since the integrity of the device has been compromised.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION 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: 17397185
• MDR Text Key: 319929945
• Report Number: 2029046-2023-01594
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2023

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: D134805
• Device Lot Number: 30994845L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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: CARTO 3 SYSTEM; THMCL SMTCH SF BID, TC, D-F; UNKNOWN CABLE