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

Catalog Number D134805

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the device was visually inspected and reddish material was found inside the pebax, no damage was observed.Then, the device was evaluated for electrical resistance and the thermocouple test failed.Further examination revealed that the thermocouple wires were broken at the tip section creating an intermittence of temperature.Due to the condition observed, a scanning electron microscope (sem) testing was performed and the results showed evidence of mechanical damage, stress marks and a hole on the surface of the pebax.It is possible that the damage was generated with an unknown object.No other anomalies were observed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint has been verified.The root cause of the damage on the pebax area cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.The tc failure is detectable in production, mitigating this failure from reaching the customer.However, despite all the controls put in place during the manufacturing of a device, inadvertent polyurethane (pu) wicking on tc wires can cause these wires to break in field, during a procedure, because of catheter fatigue.This is an inherent limitation of the design.This failure does not represent any patient safety impact.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter.Initially it was reported that at the start of the procedure, the catheter gave a temp sensor error.The cables were changed, but this did not resolve the issue.The catheter was replaced and the issue resolved.There was no patient consequence reported.Additional information was provided that the stockert generator was used in power control mode and the default settings were selected.This temperature sensor error issue was assessed as not reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster failure analysis lab received the device for assessment and on march 1, 2018, it was discovered that there was reddish material found under the pebax.This issue was assessed as not reportable.If foreign material was found underneath the pebax; however; there was no damage to the pebax integrity, then the potential that it could cause or contribute to a death or serious injury was remote.During additional assessment on march 27, 2018, the biosense webster failure analysis lab found during the sem analysis that there was evidence of mechanical damage, stress marks and a hole on the surface of the pebax.The hole on the surface of the pebax has been assessed as a reportable malfunction.The awareness date for this reportable issue is march 27, 2018.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7402845
• MDR Text Key: 105261823
• Report Number: 2029046-2018-01412
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Catalogue Number: D134805
• Device Lot Number: 17740162L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2017
• 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