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

Catalog Number D134701

Device Problems Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

The bwi product 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.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

It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the biosense webster, inc.Noted there was an exposed wire and it appeared to have a white material.Initially it was reported that an invalid force measurement alarm was displayed on the carto 3 system.The sheath had been replaced and the catheter had been pushed through the new sheath when the alert message appeared.The catheter was replaced and the issue resolved.The procedure was continued.There was no patient consequence.The force issue was assessed as not reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and found on october 31, 2019 that the polyurethane (pu) margin appeared on the tip dome.There was a potential exposed wire and it appeared to have white material.Inside the pebax sleeve there was some reddish-brown material.The returned condition of the exposed wire and the appearance of white material were assessed as reportable issues.The awareness date for this record is october 31, 2019.

Manufacturer Narrative

Originally it was reported that the biosense webster, inc.Product analysis lab received the device for evaluation and found on october 31, 2019 that the polyurethane (pu) margin appeared on the tip dome.There was a potential exposed wire and it appeared to have white material.Inside the pebax sleeve there was some reddish-brown material.After additional assessment on december 4, 2019, it was clarified that the electrode was lifted and a wire was exposed.In addition, a foreign white material was between the electrode.The clarification of the electrode was lifted, exposed wire and the foreign white material remain assessed as reportable issues.There are no changes to the 3500a codes.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

A fourier transform infra red analysis (ftir) was performed on (b)(6) 2019 which indicated that the white particle in the electrode was primarily composed of a polyethylene - based material with a second component barium sulfate.This material composite is widely used as radio pacifier along medical device industries; however, the source of origin remains unknown.The foreign white material remains assessed as reportable issue.On december 20, 2019 additional analysis was performed and the scanning electron microscope (sem) found mechanical damage and a hole on the pebax surface.The object that caused the damage was unknown.No other anomalies were observed.The hole on the pebax surface was assessed as a reportable issue and the awareness date for this finding was december 20, 2019.Therefore, added ¿h6.Device codes¿ of ¿material puncture / hole¿.The product investigation was completed on december 23, 2019.It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a thermocool® smart touch® sf uni-directional navigation catheter.It was reported that an invalid force measurement alarm was displayed on the carto 3 system.The sheath had been replaced and the catheter had been pushed through the new sheath when the alert message appeared.The catheter was replaced and the issue resolved.The procedure was continued.There was no patient consequence.The returned device was inspected and polyethylene (pu) margin appears on the tip dome.Potentially exposed wire and it appeared to have white material.Inside the pebax sleeve, it had some reddish-brown material.Then, during the second visual, it was found that electrode #2 was lifted, and a white material was observed near the electrode.Then, magnetic sensor functionality was tested on the carto and the catheter failed.Error 106 was observed.A failure analysis was performed and the catheter was dissected on the tip area.Loss of electrical continuity at the sensor was found.It was determined that the root cause was an internal failure of the sensor.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that white particle is primarily composed of a polyethylene - based material with a second component barium sulfate.This material composite is widely used as radio pacifier along medical device industries; however the source of origin remains unknown.Additionally, a scanning electron microscope (sem) testing was performed on the pebax area and the results showed mechanical damage and a hole on the pebax surface.The object that caused the damage was unknown.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint has been confirmed.The root cause of the damage on the pebax, electrodes and foreign material cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.Manufacturer's reference number: pc-(b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9373909
• MDR Text Key: 195389756
• Report Number: 2029046-2019-03935
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2020
• Device Catalogue Number: D134701
• Device Lot Number: 30208667M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNKNOWN BRAND CATHETER; UNKNOWN BRAND SHEATH; UNKNOWN BRAND SHEATH