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

Catalog Number D134805

Device Problems Break (1069); Fluid/Blood Leak (1250); Contamination /Decontamination Problem (2895); Positioning Problem (3009)

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

Event Date 09/08/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and post procedure the bwi product analysis lab identified a broken pebax.During the procedure, the sagr knob did not respond.A slight backflow of blood was observed in the irrigation of stsf.The issues were noted 1 hour after the start of the procedure.Smart touch sf catheter was removed from the cardiac cavity and flushing was performed.The device was restarted.No further problems occurred.The procedure was successfully completed.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and functional tests of the returned device were performed following bwi procedures.Visual analysis revealed that the pebax was broken with internal parts exposed.A microscopic examination was performed, and no foreign material was observed.Deflection testing was performed, and the deflection mechanism failed specifications due to the puller wire was found broken on the handle.Then, a pump and pressure gage test was performed, and the device was irrigating correctly.No water leakage was observed.The root cause of damage on pebax could be related to the handling since in the process there are control inspection points to avoid this kind of issue; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30985859l number, and no internal actions related to the reported complaint condition were identified.No foreign material was observed, however, due to the damage on pebax, was confirmed.The deflection issue reported by the customer was confirmed.The water leakage issue could not be replicated during this product investigation.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: 18414799
• MDR Text Key: 331672462
• Report Number: 2029046-2023-03119
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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: 30985859L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2023
• 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 VIZIGO SHEATH; SMARTABLATE GENERATOR; SMARTABLATE PUMP