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

Model Number ACU10135910

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

Patient Problem Unspecified Infection (1930)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

The account did not return the device for an investigation to be conducted.The account did however provide a lot number for the complaint device and the device history report was reviewed.There were no discrepancies noted which would indicate a possible cause for the issue.

Event Description

It was reported that a patient of a patent foramen ovale closure procedure came into the facility with a fever post procedure.The medical intervention provided was antibiotics for a possible infection.The current status of the patient was unknown.Additional information regarding patient status was requested but is not available.

• Type of Device: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: jason anderson ; 5010 cheshire parkway; suite 2; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 5660961
• MDR Text Key: 45341291
• Report Number: 2134070-2016-00028
• Device Sequence Number: 1
• Product Code: OWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043453
• 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: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2016
• Device Model Number: ACU10135910
• Device Catalogue Number: ACU10135910
• Device Lot Number: 1908454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• 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
• Patient Outcome(s): Required Intervention