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

Model Number D132705

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/04/2020

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 30380477m 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 ref.# (b)(4).

Event Description

It was reported that a female patient with history of heart rhythm disease, underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and developed cardiac tamponade requiring pericardiocentesis.Post-procedure during the validation phase, the patient developed cardiac tamponade.Pericardiocentesis was performed to drain the fluid from the pericardial space.Prolonged hospitalization was required.Patient had fully recovered.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.No bwi product malfunctions were reported.Transseptal puncture was not performed during the case.There¿s was no evidence of steam pop during the ablation.The catheter irrigation was set at 17 ml/min max 30 watts and 30ml/min max 50 watts.The force visualization features used included dashboard, vector and visitag.Tag index was used as stability parameter with the visitag module.Ablation index was used as coloring option.It was initially reported that the patient had a pericardial effusion, with no report of medical intervention or extended hospitalization.The event was assessed as a patient event non-serious and not fda reportable.On 12/8/2020, additional information was received which indicated the patient required pericardiocentesis and prolonged hospitalization, as such, with the new information provided, the event was reassessed as mdr reportable as a serious injury.

• Brand Name: THERMOCOOL SMART TOUCH 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: 11102455
• MDR Text Key: 224781030
• Report Number: 2029046-2020-02043
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2021
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30380477M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2020
• 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