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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-16 for * manufactured by .

Event Text Entries

[3428909] A cardiac catheterization was performed for canadian class iii angina pectoris and coronary artery disease. During the procedure, as the wire was being advanced into the proximal left circumflex artery, the distal opaque portion of the wire came off of the proximal portion. What was the original intended procedure? Cardiac catheterization. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3069932
• MDR Report Key: 3069932
• Date Received: 2013-04-16
• Date of Report: 2012-06-08
• Date of Event: 2012-06-05
• Report Date: 2012-06-08
• Date Reported to FDA: 2013-04-16
• Date Reported to Mfgr: 2013-04-22
• Date Added to Maude: 2013-04-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: CATHETER
• Product Code: OES
• Date Received: 2013-04-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 0
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-04-16