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

Model Number	10439072
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Hold for em 4.8 it was reported that a female patient born (b)(6) 1948 underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a soundstar® eco diagnostic ultrasound catheter.The patient suffered cardiac perforation requiring pericardiocentesis.During an idiopathic vt case, an atrial cardiac perforation and pericardial effusion were noticed in the patient.After using a non-bwi slo sheath to go transseptal, the slo sheath was replaced with an agilis sheath, and when going into the rv in order to do contours in the ventricles, the pericardial effusion was noticed on intracardiac echocardiography (ice) with the soundstar catheter.No ablation catheter had been inside the patient at this point in the procedure, only a soundstar catheter.The pericardial effusion and cardiac perforation were confirmed via ice and the fluoroscopy system.The medical intervention provided to the patient was a pericardiocentesis, and about 770cc of fluid was removed.The patient was reported to be in stable condition.The physician¿s opinion on the cause of this adverse event: procedure: physician believes this occurred during transseptal puncture.Patient outcome of the adverse event: fully recovered (no residual effects).Patient did stay in cardiovascular icu overnight, per hospital protocol following a complication.A transseptal puncture was performed with a brk needle.Conservatively this will be reportable because ¿no ablation catheter had been inside the patient at this point in the procedure, only a soundstar catheter¿.Since the event is life threatening and required medical 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.
Additional 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 g4069090 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).

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13420463
• Report Number: 2029046-2022-00196
• Device Sequence Number: 4676159
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: 10846835008845
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112050
• 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): 02/01/2022

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 Expiration Date: 08/19/2022
• Device Model Number: 10439072
• Device Catalogue Number: 10439072
• Device Lot Number: G4069090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 02/02/2022
• 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: AGILIS SHEATH; BRK TRANSSEPTAL NEEDLE; SLO SHEATH; THERMOCOOL SMARTTOUCH
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female