MARK V PROVIS 150 ML STERILE DISPOSABLE SYRINGE * 150-FT-Q

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-12 for MARK V PROVIS 150 ML STERILE DISPOSABLE SYRINGE * 150-FT-Q manufactured by Medrad, Inc..

Event Text Entries

[20954597] Upon performing a left ventriculogram in the 30 degree right anterior oblique (rao 30) view using a power injection of contrast, there appeared to be a small foreign body in the left ventricle or left atrium after the ventriculogram. The patient had no apparent neurologic complications associated with this and the foreign body was not seen on fluoroscopy following the case. Question if the foreign body seen could have been crystallized contrast.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2065332
• MDR Report Key: 2065332
• Date Received: 2011-04-12
• Date of Report: 2011-04-12
• Date of Event: 2011-04-11
• Report Date: 2011-04-12
• Date Reported to FDA: 2011-04-12
• Date Added to Maude: 2011-04-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• 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 Sequence Number: 1

• Brand Name: MARK V PROVIS 150 ML STERILE DISPOSABLE SYRINGE
• Generic Name: INTERVENTIONAL STERILE DISPOSABLE SYRINGE
• Product Code: DXT
• Date Received: 2011-04-12
• Model Number: *
• Catalog Number: 150-FT-Q
• Lot Number: 108577
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDRAD, INC.
• Manufacturer Address: 625 ALPHA DR. PITTSBURGH PA 15238 US 15238

Device Sequence Number: 2

• Brand Name: HIGH PRESSURE TUBING 1200 PSI (82,73) BAR (30")
• Generic Name: HIGH PRESSURE TUBING
• Product Code: FPK
• Date Received: 2011-04-12
• Model Number: *
• Catalog Number: HPT300E
• Lot Number: H202153
• ID Number: *
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MERIT MEDICAL SYSTEMS, INC.
• Manufacturer Address: 1600 WEST MERIT PKWY. SOUTH JORDAN UT 84095 US 84095

Device Sequence Number: 3

• Brand Name: INFINITI PIGTAIL DIAGNOSTIC CATHETER
• Generic Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Product Code: DQO
• Date Received: 2011-04-12
• Model Number: *
• Catalog Number: 538-453S
• Lot Number: 15327789
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: CORDIS
• Manufacturer Address: 14201 NORTH WEST 60TH AVENUE MIAMI LAKES FL 33014 US 33014

Device Sequence Number: 4

• Brand Name: OPTIRAY
• Generic Name: RADIOPAQUE CONTRAST AGENT
• Product Code: KTA
• Date Received: 2011-04-12
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: MALLINCKRODT
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-04-12