MAUDE Adverse Event Report: STERILMED, INC. UNKNOWN_STERILMED

Catalog Number UNKNOWN_STERILMED

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

Patient Problem Cardiac Tamponade (2226)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

Multiple attempts have been made to get clarification on the specific device information, however no further information has been made available.The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Manufacturer's ref.No: (b)(4).There are 2 reports for this event: 2134070-2019-00122.

Event Description

It was reported that a patient underwent a right atrial flutter procedure and a cardiac tamponade occurred.When attempting to place the reprocessed coronary sinus (cs) catheter, the device would cannulate the middle cardiac vein and would continually lose contact.The device was replaced to another reprocessed cs catheter, which also had difficulty being placed.After nearly 40 minutes of manipulation, the second cs catheter was able to be placed in the coronary sinus.The procedure was continued, and bidirectional block was successfully achieved.When manipulating the intracardiac echocardiogram catheter, a pericardial effusion was noted.Pericardiocentesis was performed to stabilize the patient.The physician believed the perforation was due to the coronary sinus catheters.Additionally, the physician has not said that there was a malfunction or issue with any of the devices that lead to the complication.The patient has since fully recovered without any need for additional medical intervention.

• Brand Name: UNKNOWN_STERILMED
• Type of Device: UNKNOWN
• 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 ; 5010 cheshire parkway; ste 2; plymouth, MN 55446 ; 9497898687
• MDR Report Key: 8465849
• MDR Text Key: 140455189
• Report Number: 2134070-2019-00121
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN_STERILMED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention