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

Catalog Number D134701

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.A manufacturing record evaluation was performed for the finished device 30156799l number, and no internal action related to the reported complaint condition were identified.Manufacturer¿s ref # (b)(4).

Event Description

It was reported a patient underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab has identified foreign material on near the tip of the catheter.It was initially reported by the customer that during procedure, there was error code 106 displayed on the carto 3 system.The cable was replaced and the issue remained.The catheter was replaced, and the issue resolved.There was no patient consequence.The customers reported issue of error 106 is not mdr reportable since there is no risk to patient due to the procedure delay.On 5/16/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis identified ¿a bulge near ring 1 and it appears to be white material 0.5 cm from the end of the distal tip.¿ these findings were reviewed and assessed as mdr reportable for the foreign material.There was no report of foreign material made by the customer.On 05/31/2019, during further evaluation, a scanning electron microscope (sem) was performed.The sem analysis show electrode two with foreign material underneath.Electrode integrity is not damaged; however, pu border is separated from the ring.Object that cause the damage is unknown.No other anomalies were observed.The finding of foreign material continues to be mdr reportable.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 05/16/2019 and has reassessed this complaint as reportable.

Manufacturer Narrative

It was reported a patient underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab has identified foreign material on near the tip of the catheter.It was initially reported by the customer that during procedure, there was error code 106 displayed on the carto 3 system.The cable was replaced and the issue remained.The catheter was replaced, and the issue resolved.There was no patient consequence.Device evaluation details: the device evaluation has been completed.The device was inspected and a bulge was observed near the ring # 1, white material was observed on the tip.Then, during the second visual inspection the electrode #2 was observed lifted with foreign material underneath.Then, the magnetic sensor functionality was tested on 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.Additionally, a scanning electron microscope (sem) testing was performed on the damage area and the results showed electrode two with foreign material underneath.Electrode integrity is not damaged; however, polyurethane (pu) border is separated from the ring.Object that caused the damage is unknown.No other anomalies were observed.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that the white particle is primarily composed of a polyethylene-based material with barium sulfate.This material composite is widely used as radio pacifier along medical device industries.This finding has been reviewed and determined this finding of foreign material continues to be mdr reportable.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the internal failure of the sensor cannot be determined, however, an internal action was open to investigate this issue.The root cause of the foreign material observed 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 manipulation between the catheter and the sheath during the procedure, however, this cannot be conclusively determined.Manufacturer¿s ref # (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: 8677305
• MDR Text Key: 150159980
• Report Number: 2029046-2019-03245
• 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
• Report Date: 03/25/2019

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: 01/14/2020
• Device Catalogue Number: D134701
• Device Lot Number: 30156799L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/06/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1