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

Model Number	10438577
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).This event was also reported by the manufacturer in mdr 2029046-2020-00175.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old female patient ((b)(6) kg) underwent an atrial fibrillation (afib) ablation procedure for soundstar® eco diagnostic ultrasound catheter and suffered vessel perforation requiring no interventions.During the procedure, when trying to get access into the right femoral vein, they perforated the femoral vein.There was a drop-in patient's blood pressure.However, no medical/surgical intervention was required as the vessel was self-closing.The reminder of the procedure was aborted, and the patient was transferred to the coronary care unit (ccu).The patient was reported in stable condition.Physician's opinion regarding the cause of the adverse event is that the soundstar catheter perforated the vein at a tight turn in the vein.Extended hospitalization was not required.Patient's outcome was fully recovered.A thermocool smart touch sf catheter was inside the body, but radio frequency delivery was never applied.

• Brand Name: SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine, ca
• MDR Report Key: 9688691
• Report Number: 3009498591-2020-00002
• Device Sequence Number: 19746322
• Product Code: OBJ
• UDI-Device Identifier: 10846835008838
• UDI-Public: 10846835008838
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2020
• Report Date (Section F): 02/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 10438577
• Device Catalogue Number: 10438577
• Device Lot Number: E5077951
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/15/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 68 YR
• Patient Weight: 110
• Date Report Sent to FDA: 02/10/2020