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 Problems Bradycardia (1751); Cardiac Tamponade (2226)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

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 30579397l number, and no internal action 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 (b)(6) premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and patient suffered cardiac tamponade (ct) requiring pericardiocentesis.Bradycardia developed during ablation near the left ventricular posterior papillary muscle, and blood pressure decreased.This occurred one hour after the start of catheter use and immediately after ablation around the left ventricular posterior papillary muscle.Pericardial drainage was performed after confirming the presence of a small amount of pericardial fluid by echography.Blood pressure stabilized quickly.Noradrenaline was administrated after blood pressure decreased, blood pressure was stable, but only slight pericardial effusion was noted.Pericardial drainage (via venous blood approach) was performed.After drainage, blood pressure was stabilized, and the procedure was continued.There was no pericardial effusion even after the end of the case, and blood pressure was stable.The patient was taken back to the general ward for observation.Patient outcome of the adverse event was reported as improved.The physician commented no malfunction was observed on the catheters.He thinks the cause of the tamponade was not due to the catheters.This adverse event was discovered during use of biosense webster products.Prior to noting the ct, ablation was performed.There was no evidence of a steam pop.The event occurred during the ablation phase.No error messages were observed on the biosense webster equipment during the procedure.

• 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12763651
• MDR Text Key: 283840390
• Report Number: 2029046-2021-01901
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2021

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: 06/09/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30579397L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 60 KG