MAUDE Adverse Event Report: STERILMED, INC. SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER; CATHETER, ELECTRODE RECORDING

Model Number R10439011

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported that a patient underwent premature ventricular contraction (pvc) ablation procedure with soundstar eco 8f diagnostic ultrasound catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, shortly after ablation, a perforation of the right ventricle was discovered by intracardiac echocardiography (ice).The event occurred post ablation and post use of biosense webster products.Transseptal was not performed.A pericardiocentesis was performed and 1000cc of fluid was extracted.The patient was reported to be in stable condition.The patient had fully recovered.There is no information about the hospitalization.There was no evidence of steam pop.Caller stated the physician suspected that a reprocessed soundstar eco catheter (soundstar eco 8f diagnostic ultrasound catheter) caused the perforation in the right ventricle.The ablation catheter was in the left ventricle at the time.There was no ablation performed in the left ventricle.The system did no present any error messages.There was no specific challenge with placing or advancing the catheter.There was no anatomical or technical characteristic that could have contributed to the event.Graph, dashboard, vector, visitag modules were used for force visualization.The visitag module was used with the following parameters: tag size 3mm, force-over-time 25% 3g, no additional filters.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 7/24/2020.The device evaluation was completed on 8/18/2020: it was reported that a patient underwent premature ventricular contraction (pvc) ablation procedure with soundstar eco 8f diagnostic ultrasound catheter.During the procedure, shortly after ablation, a perforation of the right ventricle was discovered by intracardiac echocardiography (ice).The event occurred post ablation and post use of biosense webster products.Transseptal was not performed.A pericardiocentesis was performed and 1000cc of fluid was extracted.The patient was reported to be in stable condition.The patient had fully recovered.There is no information about the hospitalization.There was no evidence of steam pop.Caller stated the physician suspected that a reprocessed soundstar eco catheter (soundstar eco 8f diagnostic ultrasound catheter) caused the perforation in the right ventricle.The ablation catheter was in the left ventricle at the time.There was no ablation performed in the left ventricle.The returned complaint device was submitted to full functional testing.The device triggered an error on the ucm - displaying error code 203.The testing associate noted that the error code description was - no 1 wire component connected.The testing associate did note that the complaint device passed its mobility testing.The full electrical testing prior to the shipment to the field was reviewed, and it was noted that the device passed its this full electrical testing showing no calibration issues prior to its shipment.As the device was removed from its packaging, and handled in the field, as well as being coiled for its return shipment, the root cause for the defect is uncertain.It should be noted that the account did not cite any errors from the generator during their use of the device in the field.As no issues with the mobility of the imaging catheter could be found, and the fmea for the complaint device lists the potential hazard of "does not work at all, not recognized by system, generates error code" as low/broadly acceptable, the account's complaint, per the injury in the field, could not be confirmed.A manufacturing record evaluation (mre) was conducted for lot 2127637.No internal actions were identified.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 8F DIAGNOSTIC ULTRASOUND CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 10283045
• MDR Text Key: 201427677
• Report Number: 2134070-2020-00005
• Device Sequence Number: 1
• Product Code: OWQ
• UDI-Device Identifier: 10888551045087
• UDI-Public: 10888551045087
• Combination Product (y/n): N
• PMA/PMN Number: K161700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2021
• Device Model Number: R10439011
• Device Catalogue Number: R10439011
• Device Lot Number: 2127637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: BWI CARTO 3 SYSTEM.; BWI-THMCL SMTCH SF BID, TC, D-F.
• Patient Outcome(s): Life Threatening; Required Intervention