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 few days after a pfo closure case, the patient came in with an infection at the incision site.It was reported that the medical intervention provided was antibiotics.The status of the patient was unknown.Additional information on patient status was requested, but no further information was reported.

• 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: 5659308
• MDR Text Key: 45297218
• Report Number: 2134070-2016-00027
• 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: 04/21/2016

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: 01/17/2017
• Device Model Number: ACU10135910
• Device Catalogue Number: ACU10135910
• Device Lot Number: 1917149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2016
• 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