MAUDE Adverse Event Report: STERILMED, INC.; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number BIO10438577

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

Patient Problem Pericardial Effusion (3271)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer as of the date of this report.A supplemental report will be sent after the device evaluation if the device is received.No lot number was reported so the device history record could not be reviewed for discrepancies.

Event Description

It was reported that during an idvt case, a pericardial effusion was noticed during mapping when the catheter was in an incorrect location.The pericardial effusion was confirmed by transthoracic echo.It was reported that the medical intervention provided was a pericardiocentesis and it was unknown how much fluid was removed.The patient was reported to be in stable condition.

• Type of Device: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: jay anderson ; 5010 cheshire parkway; suite 2; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 5171298
• MDR Text Key: 29046727
• Report Number: 2134070-2015-00050
• Device Sequence Number: 1
• Product Code: OWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BIO10438577
• Device Catalogue Number: BIO10438577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO3,COOLFLOWPUMP,SMRTTOUCH CATHTR,SNDSTR CATHTR
• Patient Outcome(s): Required Intervention