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 Cardiac Tamponade (2226)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30593325l number, and no internal actions related to the complaint was found during the review.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) male patient (72kg) underwent a ventricular tachycardia (vt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.Cardiac tamponade, after the treatment on the end side was completed, epi was mapped by decanav, and when additional mapping was performed by exchange to thermocool® smart touch® sf bi-directional navigation catheter, the patient¿s blood pressure decreased and tamponade was confirmed by soundstar.Drainage was performed.Drainage of venous blood from epi placed sheath, transfusion, situations requiring fresh frozen plasma (ffp).The right ventricle (rv) may have been scratched by the catheter during mapping from the epi side.Ablation was completed and follow-up for complications did not improve.Percutaneous cardiopulmonary support (pcps) was inserted in the catheter room, and surgical hemostasis was achieved with an open operation.The physician commented that the catheter operation in epi may have been the cause.On the 25th, the status of the patient was checked.Operation was successfully completed and recovery was awaited.Additional information was received.This adverse event was discovered during use of biosense webster products.No information and no further information will be provided on patient outcome of event and whether patient required extended hospitalization.Prior to noting the cardiac tamponade, ablation was performed.No steam pop was reported.

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30593325l number, and no internal actions related to the complaint was found during the review.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) male patient (72kg) underwent a ventricular tachycardia (vt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.Cardiac tamponade, after the treatment on the end side was completed, epi was mapped by decanav, and when additional mapping was performed by exchange to thermocool® smart touch® sf bi-directional navigation catheter, the patient¿s blood pressure decreased and tamponade was confirmed by soundstar.Drainage was performed.Drainage of venous blood from epi placed sheath, transfusion, situations requiring fresh frozen plasma (ffp).The right ventricle (rv) may have been scratched by the catheter during mapping from the epi side.Ablation was completed and follow-up for complications did not improve.Percutaneous cardiopulmonary support (pcps) was inserted in the catheter room, and surgical hemostasis was achieved with an open operation.The physician commented that the catheter operation in epi may have been the cause.On the 25th, the status of the patient was checked.Operation was successfully completed and recovery was awaited.Additional information was received.This adverse event was discovered during use of biosense webster products.No information and no further information will be provided on patient outcome of event and whether patient required extended hospitalization.Prior to noting the cardiac tamponade, ablation was performed.No steam pop was reported.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13023010
• MDR Text Key: 285673200
• Report Number: 2029046-2021-02204
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30593325L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7FR DECAN,11P,D,2.4MMLE,282MM,; SOUNDSTAR ECO SMS 8F CATHETER; UNKNOWN BRAND SHEATH; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 72 KG