CARDIOMEMS ENDOSURE DELIVERY SYSTEM S2-2080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-10-05 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM S2-2080 manufactured by Cardiomems, Inc..

Event Text Entries

[734634] The sensor was placed without any issue. When the sensor was released from the delivery system if fell down into the iliac artery aneurysm. The sensor was placed back into the aortic aneurysm sac, but each time it fell down to the iliac. After some time, the sensor was removed from the pt without issue.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004936110-2007-00016
• MDR Report Key: 929972
• Report Source: 07
• Date Received: 2007-10-05
• Date of Report: 2007-10-05
• Date of Event: 2007-09-20
• Date Mfgr Received: 2007-09-20
• Date Added to Maude: 2007-12-10
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: 387 TECHNOLOGY CIRCLE NW SUITE 500
• Manufacturer City: ATLANTA GA 30313
• Manufacturer Country: US
• Manufacturer Postal: 30313
• Manufacturer Phone: 6786512323
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CARDIOMEMS ENDOSURE DELIVERY SYSTEM
• Generic Name: INTRAVASCULAR PRESSURE SENSOR
• Product Code: NQH
• Date Received: 2007-10-05
• Catalog Number: S2-2080
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 905003
• Manufacturer: CARDIOMEMS, INC.
• Manufacturer Address: ATLANTA GA 30313 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2007-10-05