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

Model Number D134801

Device Problems Signal Artifact/Noise (1036); Break (1069); High Readings (2459)

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

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: the device was returned to biosense webster for evaluation.A visual inspection, cool flow pump, temperature and impedance, and electrical tests of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned smart touch bidirectional sf device revealed that the pebax of the device was broken, the root cause of the damaged pebax could not be conclusively determined, but it was concluded, that it may have happened outside of bwi manufacturing facilities.Electrical current leakage issues were observed during the generator test, further investigation revealed corrosion on the electrical components inside the handle and an open circuit on the tip area causing these failures.An irrigation test was performed, and water leakage was observed from the handle.For these conditions, the manufacturing team performed an investigation to find the root cause, the investigation results showed that these issues are related to the manufacturing process since the luer hub component was not positioned by specifications.Additionally, a scanning electron microscope (sem) testing was performed on corrosion samples and revealed the presence of saline solution.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device 30567549l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: when radiofrequency (rf) current is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned of coagulum if present.Electrocardiogram (ecg) noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient; to resolve this situation, verify the proper connection.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

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 a damaged pebax.The finding was identified on (b)(6) 2022.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.There was high impedance, high temperature errors and the case was cancelled.After the ablation catheter was inserted into the patient¿s body, noise was run at all electrical potentials and impedance was over 200 and temperature display was over 100.Noise occurred.At the time of the noise, the catheter was in the body, both in the superficial heart and in the carto3 lab.The procedure was cancelled during procedure but before ablation.A transseptal puncture as performed prior to case cancellation.The patient did not require extended hospitalization as a result of the procedure cancellation.There were no reports of patient consequences.Noise issue is not mdr-reportable.High impedance is not mdr-reportable.Cracked/broken pebax is mdr-reportable.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13694885
• MDR Text Key: 289185686
• Report Number: 2029046-2022-00413
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2022

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 Expiration Date: 05/26/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30567549L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Initial Date Manufacturer Received: 02/13/2022
• Initial Date FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• 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: JPN CARTO 3 SYSTEM; SMARTABLATE GENERATOR; UNSPECIFIED TRANSSEPTAL NEEDLE