MAUDE Adverse Event Report: STERILMED, INC. N/A; IMAGING CATHETER

Model Number R10439011

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

Patient Problem Pericardial Effusion (3271)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned to the manufacturer at the time of this report.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history was unable to be reviewed as no lot not was supplied by the customer for this device.Additional products in use were: carto 3 system ser# 11415; smart touch catheter: cat# d134805; pentaray catheter: cat# d128211.Manufacturer's ref no: (b)(6).

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) procedure with a soundstar eco 8f diagnostic ultrasound imaging catheter and developed pericardial effusion and torsades de points requiring cardiopulmonary resuscitation (cpr) to stabilize and pericardiocentesis.During the transseptal phase, effusion occurred while working in the right ventricle (rv).Torsades de points was detected.Cpr was performed to stabilize the patient followed by pericardiocentesis.Patient required transfer to the critical care unit (ccu) for observation.Patient status improved after the adverse event.It is unknown whether the quadriplegic state of the patient may have contributed to the adverse event.Physician did provide a causality opinion; that the soundstar in the rv caused the effusion.There were no reported malfunctions with soundstar catheter.There were no issues or errors reported on any generators or equipment during the procedure.Transeptal puncture was performed with an unknown transeptal needle and a slo curve type saint jude medical 8.5 sheath.Generator was set on smart ablate at 40 watts.Anticoagulation was provided to the patient during the procedure.Activated clotting time (act) was maintained at 300-350.The power was not titrated during ablation.The overall ablation time at the site of injury was 3 hours.There is no further information regarding generator parameters, generator settings, power titration, or last ablation cycle time at the site of injury.Irrigated catheter flow was set at high.There was no noted catheter proximity during the event.The catheter was not zeroed after the initial warm-up phase post catheter connection to the carto 3 patient interface unit (piu).There is no information regarding shaft proximity or interference value.

• Brand Name: N/A
• Type of Device: IMAGING CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7447834
• MDR Text Key: 106137270
• Report Number: 2134070-2018-00001
• Device Sequence Number: 1
• Product Code: OWQ
• 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: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R10439011
• Device Catalogue Number: R10439011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention