MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR RMT 4MM; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number	BN7TCFJ4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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 or Problem Description
It was reported that an unknown female patient underwent a supraventricular tachycardia (svt) ablation procedure with an unk_navistar rmt 4mm.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that the patient had a cardiac effusion during a svt case.Prior to noticing the effusion, they had done septal lesions on the right side for atrioventricular nodal reentry tachycardia (avnrt).For those lesions they used a 4mm navistar bi-directional ablation catheter (fj curve) and then before going transeptal they switched to a smart touch surround flow (stsf) catheter (df curve).After going transeptal, while they were getting ready to map and before any ablation was done with the stsf catheter they noticed the effusion.It is unknown whether the blood pressure or any other metrics changed before it was noticed.The effusion was confirmed using the soundstar catheter and an intracardiac echocardiogram.After the effusion was confirmed, all instruments except for the soundstar catheter were removed from the patient and they then performed a pericardiocentesis.It is unknown how much fluid was removed.No other medical intervention was necessary but the case was abandoned.At the time of the call, the patient was stable but the caller was unsure if the patient was admitted overnight for observation.The patient was female and "petite", but had no other information on age or weight.The case was not part of a clinical study.The medical team reported that the following were the bwi products used in the procedure: hiss catheter.Quad catheter, cs catheter, soundstar catheter, 4mm navistar bi-directional ablation catheter (fj curve), and a smart touch surround flow ablation catheter (df curve).Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention 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: UNK_NAVISTAR RMT 4MM
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14219691
• Report Number: 2029046-2022-00894
• Device Sequence Number: 4261550
• Product Code: LPB
• UDI-Device Identifier: 10846835003031
• UDI-Public: 10846835003031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S12
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: BN7TCFJ4L
• Device Catalogue Number: BN7TCFJ4L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HISS CATHETER; QUAD CATHETER; SOUNDSTAR CATHETER; STSF ABLATION CATHETER (DF CURVE)
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Female