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

Model Number ACU10135936

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

Patient Problem Pericardial Effusion (3271)

Event Date 09/02/2015

Event Type  Injury  

Manufacturer Narrative

It was reported that the device was disposed of by the customer, it will not be returned for evaluation.The device history record was reviewed and no discrepancies were found.

Event Description

It was reported that during an asd closure, a pericardial effusion was noticed and confirmed by ice.Caller reported that protamine was administered to the patient and the effect of heparin was reversed.The patient was reported to be in stable condition.Upon request for additional information, it was reported that it was not thought that the ice catheter caused the effusion.It was assumed that the gore device or the sheath for the gore device caused the effusion.

• Type of Device: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: jay anderson ; 11400 73rd ave n; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 5100260
• MDR Text Key: 26616789
• Report Number: 2134070-2015-00047
• 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
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2016
• Device Model Number: ACU10135936
• Device Catalogue Number: ACU10135936
• Device Lot Number: 1861721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• 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