MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	10438577
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 a male patient born on (b)(6), ((b)(6)kg) underwent an atrial fibrillation (afib) ablation procedure with a soundstar® eco diagnostic ultrasound catheter.The patient suffered a vascular perforation.During an afib case, a perforation of the left femoral was discovered by flouro and contrast.The patient's blood pressure was stable and was under observation for about 20 minutes and no medical intervention in the current moment was provided.The patient was reported to be in stable condition.The physician believes that when advancing/enforcing of the intra-cardiac echocardiography (ice) catheter might have caused the perforation.The decanav was used after the ice catheter.It was also reported one of the current cable got stuck in a port on the been and when the patient got transferred the green patch cable got torn.The adverse event was discovered during the use of biosense webster products.The physician pushed too hard in the femoral vein with the ultrasound catheter without understanding the venous anatomy and perforated.He does not think it was a product malfunction, simply just forced a catheter without checking.The patient outcome of the adverse event is fully recovered.The patient did not require extended hospitalization because of the adverse event.Generator information: stockert smartablate, ref: m490002, sn: (b)(4).Since the event is life threatening and might result in permanent impairment of a body function or permanent damage of a body structure, it is to be considered serious and mdr-reportable.

• Brand Name: SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 13237965
• Report Number: 3023245-2022-00001
• Device Sequence Number: 19894525
• Product Code: OBJ
• UDI-Device Identifier: 10846835008838
• UDI-Public: 10846835008838
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2022
• Report Date (Section F): 01/12/2022

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: 10438577
• Device Catalogue Number: 10438577
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/07/2022
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM.; DECANAV CATHETER.; SMARTABLATE GENERATOR.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Date Report Sent to FDA: 01/12/2022