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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30368324m 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 female patient in their fifties underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.At the beginning of the procedure, no pericardial effusion was noticed.Later in the case, while using the stsf catheter, they noticed fluid in the pericardial space.Pericardial effusion was confirmed by intracardiac echocardiography (ice).Pericardiocentesis was performed to drain 1800 ml of fluid from the pericardial sac.After 30 minutes waiting period, they confirmed fluid was no longer filling the pericardial sac.The patient was reported to be in stable condition.Prolonged hospitalization was required.Patient had fully recovered from the event.Physician is uncertain about the causality of the event and believes the issue was procedure related and likely had occurred during the transseptal puncture with a brk st.Jude needle.No ablation was done prior to the adverse event occurrence.No bwi product malfunctions nor error messages were reported.The catheter irrigation was set at 8ml/min at <30 watts and 15ml/min at >30 watts.Standard surpoint recommendation settings were used: 2.5 mm, 3 sec, 25% at 3 grams.Ablation index was set as coloring option.This event is being conservatively reported under the bwi ablation catheter since there¿s no conclusive evidence that its usage did not contribute to the causality of the event.Since this event is life threatening and required intervention and prolonged to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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: 11016813
• MDR Text Key: 222317804
• Report Number: 2029046-2020-01950
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2020

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: 03/09/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30368324M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention