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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 (b)(6) year old male patient underwent an atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered phrenic nerve paralysis.Right after the superior vena cava (svc) ablation, phrenic nerve palsy was confirmed and the procedure was completed.The patient was conscious after surgery and there was no problem with its response.The clinical course will be monitored.There were no additional medical or surgical intervention provided and the patient was continually being observed.The patient¿s outcome was unchanged.No prolonged hospitalization was required.The physician commented that the opinion is that there is no causal relationship with the product.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 05-aug-2021.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).

Manufacturer Narrative

Additional information was provided on 02-jul-2021 supplying extra concomitant products.Therefore, added the extra products to the "d10.Concomitant medical products and therapy dates" field.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

It was reported that a 45 year old male patient underwent an atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered phrenic nerve paralysis.The device evaluation was completed on 14-oct-2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned product revealed that no damage or anomalies were observed on the smart touch sf catheter.Per the event, several tests were performed.The magnetic, temperature and force features were tested and error 106 was displayed in the screen.In addition, the product was deflecting correctly and irrigation failed.Therefore, the catheter was dissected on the tip area, loss of electrical continuity of the green paired wires to sensor was found.Concluding that is an internal failure of the sensor.A failure analysis was performed and the catheter was dissected, and it was found the irrigation blocked with a foreign material.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed foreign material is primarily composed of a biological-based material, human tissue or fluid.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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
• MDR Report Key: 12094195
• MDR Text Key: 265631976
• Report Number: 2029046-2021-01025
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30527226M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 07/02/2021; 08/05/2021; 10/14/2021
• Supplement Dates FDA Received: 07/27/2021; 08/09/2021; 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO3 EXTERNAL REFPATCH 6PACK.; PENTARAY NAV ECO 7FR, D, 2-6-2.; SMARTABLATE IRR TUBE SET.; SOUNDSTAR ECO SMS 8F CATHETER.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Other
• Patient Age: 45 YR