MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER; SIMILAR DEVICE SNDSTR10, 510K # K070242

Model Number M-5723-00

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Tamponade (2226)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Concomitant medical products: smart touch bidirectional sf catheter, model #: d-1348-05-s, lot #: 17630920l.(b)(4).

Event Description

It was reported that a female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure for premature ventricular contractions (pvcs) with a soundstar catheter and suffered a cardiac tamponade requiring pericardiocentesis and surgical intervention.Approximately 45 minutes after ablation, the patient became hypotensive and a tamponade was confirmed via intracardiac echocardiogram.Pericardiocentesis yielded greater than 1000ml.Platelets were ordered and the patient was transferred to the operating room for a surgical intervention.Patient required extended hospitalization as a result of the adverse event.It was noted that the injury was not at an ablation site.There were no factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was related to the soundstar catheter.No transseptal puncture was performed.There is no sheath information.Generator was set on power control mode with default settings.Power was titrated during ablation, from 15 watts to 25 watts.Generator settings at the time of injury were not reported, as the injury did not occur during ablation and was not a result of ablation.Overall ablation time and last ablation cycle time at the site of injury were not reported, as there was no ablation at the site of injury.Irrigated catheter flow was set on standard settings.Patient did not receive anticoagulant during the procedure.There is no information regarding shaft proximity interference value.Smarttouch bidirectional sf catheter was not in close proximity to another catheter.Smarttouch bidirectional sf catheter was zeroed after the initial warm-up phase post catheter connection to the carto® 3 patient interface unit.Carto® 3 system did not indicate to re-zero the catheter.There were no errors reported on any biosense webster, inc.Equipment during the procedure.

• Brand Name: SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER
• Type of Device: SIMILAR DEVICE SNDSTR10, 510K # K070242
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6586234
• MDR Text Key: 75817670
• Report Number: 2029046-2017-00178
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-5723-00
• Device Catalogue Number: M572300
• Device Lot Number: OEM_M-5723-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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