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

Model Number D134805

Device Problems Image Orientation Incorrect (1305); Material Puncture/Hole (1504)

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

Event Date 01/19/2023

Event Type  malfunction  

Event Description

A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified reddish material inside the pebax and a hole on the surface.It was initially reported by the customer that during ablation, the vector of contact force was turned proximal to the catheter, and the contact became high.No abnormality was found in the behavior of contact force except when ablating.The issue occurred after approximately 40 minutes of catheter use.Zeroing, reconnection of cables, replacement of cables, etc.Were performed, but the issue was not resolved.The catheter was replaced and the issue resolved.The procedure was completed without patient's consequence.High force is not mdr-reportable.Force vector inverted is not mdr-reportable.Hole in the pebax is mdr-reportable.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual analysis of the returned catheter revealed reddish material inside the pebax and a hole on the surface.The magnetic and force feature were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed; however, the hole at the pebax with reddish material inside it could be related to the force issue.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.A manufacturing record evaluation was performed for the finished device 30916899l number, and no internal actions related to the reported complaint condition were identified.It should be noted that device failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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: 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: 16616948
• MDR Text Key: 312228865
• Report Number: 2029046-2023-00638
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30916899L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• 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