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

Catalog Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.A manufacturing record evaluation was performed for the finished device and no internal actions were found during the review.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) catheter and suffered vessel perforation (pulmonary vein perforation) requiring intubation.The patient entered to the room, transseptal puncture was performed with brockenbrough technique and sound merge was performed with the soundstar eco 8fg ultrasound catheter.Then, the patient¿s condition suddenly changed at the time of left atrium (la) contrast.Patient¿s peripheral capillary oxygen saturation rose up to 68%, and blood pressure dropped to 70 units.The patient started to cough intensely.The physician then indicated that it was difficult to continue the procedure and proceeded to intubate the patient and connected patient to the respirator.Drainage was not performed.However, the ablation was discontinued because the patient would not stabilize.The patient was transferred to body surface echo and contrast-enhanced computed tomography examination to investigate the cause.The physician commented that the cause was not clear, but when the physician took the sheath to right superior pulmonary vein (rspv) and left superior pulmonary vein (lspv) at the time of la imaging, there was a possibility that the pulmonary vein was damaged which led to a decline in patient¿s condition (coughing, and blood mixing).The contact force at the time of ablation had an acceptable value.There¿s no information regarding extended hospitalization.Patient¿s outcome is unknown.The physician commented that the phenomenon that caused this event occurred during sheath placement or catheter manipulation at the time of imaging.No further information is available.This event has been reviewed with the biosense webster representative on 8/1/2019 and it was determined the issue is referring to a pulmonary vein perforation with under the ablation catheter as it was in the sheath at the time.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) catheter and suffered vessel perforation (pulmonary vein perforation) requiring intubation.In the initial, the concomitant products were omitted in error.The concomitant products section of this report has been updated with:soundstar eco 8fg ultrasound catheter, lasso® nav eco variable catheter, and lasso® nav eco variable catheter.Manufacture reference no: pc-000501918.

Manufacturer Narrative

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool smart touch sf bidirectional catheter and suffered vessel perforation (pulmonary vein perforation) requiring no surgical intervention but intubation.On (b)(6) 2019, additional information was received indicating the patient gender is male.The patient¿s outcome was improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8859396
• MDR Text Key: 153251309
• Report Number: 2029046-2019-03505
• 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
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30209186M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASSO NAV 2515,12P SPLITHANDLE; LASSO NAV 2515,12P SPLITHANDLE; SOUNDSTAR ECO SMS 8F CATHETER; LASSO NAV 2515,12P SPLITHANDLE; LASSO NAV 2515,12P SPLITHANDLE; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention