MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133605IL

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The device history record (dhr) for the lot number 17736489m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter.Initially it was reported that during the procedure, error code '101' was displayed, the catheter could not apperceive an electric signal and could not build the model.The catheter was exchanged to complete the procedure.No patient consequences were reported.The 101 error code and the issue of being unable to build the model were assessed as not reportable.The user will not be able to use the device and will have to replace it.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The signal issue was also assessed as not reportable.The risk to the patient was low.The biosense webster failure analysis lab received the device for evaluation.On may 28, 2018, it was discovered that there was a cut on the pebax and metal was exposed.The cut with metal exposed was assessed as a reportable malfunction.The awareness date for this reportable malfunction is may 28, 2018.On june 4, 2018, a scanning electron microscope (sem) analysis showed evidence of mechanical damage, stress marks and a hole on the surface of the pebax.The pebax integrity issue which was discovered on may 28, 2018 was confirmed through the sem analysis.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter.It was reported that during the procedure, error code '101' was displayed, the catheter could not apperceive an electric signal and could not build the model.The catheter was exchanged to complete the procedure.No patient consequences were reported.The biosense webster failure analysis lab received the device for evaluation.On may 28, 2018, it was discovered that there was a cut on the pebax and metal was exposed.The cut with metal exposed was assessed as a reportable malfunction.The awareness date for this reportable malfunction is may 28, 2018.On june 4, 2018, a scanning electron microscope (sem) analysis showed evidence of mechanical damage, stress marks and a hole on the surface of the pebax.The pebax integrity issue which was discovered on may 28, 2018 was confirmed through the sem analysis.The returned device was visually inspected and the pebax was found cut with metal exposed.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, electrical test was performed and the catheter failed, no electrical readings were observed on electrode #2.Also the thermocouple values were found out of specification.A failure analysis was performed and the catheter was dissected on the tip area, the electrical wire was found broken and an electrical intermittence on the tip area creating the temperature issue causing the improper electrical signal.Additionally, a scanning electron microscope (sem) testing was performed on the damaged area 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 was confirmed.The root cause of the damage on the pebax and the electrical wire issue cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Thermocouple failure is detectable in production.However, the wires can be broken during the procedure due to the manipulation of the device.This failure does not represent any patient safety impact.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7628174
• MDR Text Key: 112565891
• Report Number: 2029046-2018-01724
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2018
• Device Catalogue Number: D133605IL
• Device Lot Number: 17736489M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1