MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VENTURE CARDIAC CATHETER; CATHETER, PERCUTANEOUS

Lot Number 580195

Device Problem Defective Device (2588)

Patient Problems Ventricular Tachycardia (2132); Vascular Dissection (3160); Shock from Patient Lead(s) (3162)

Event Date 04/01/2016

Event Type  Injury  

Event Description

Ventricular tachycardia; during a cardiac catheterization, the dr documented in his report using a defective venture cardiac catheter.In his report it states "attempted to use a venture catheter to help direct the wire into the lad.After advancing the catheter into the mid lad near the bifurcation i puffed contrast, and angiography revealed no flow in the left main, lad, or circumflex.The venture catheter was immediately removed and taken out of the body.It (venture catheter) was examined and was noted that there was a small metal protrusion from the tip of the catheter that likely caused dissection.This catheter was given to the company rep to further evaluate.Further down in report the provider documented "due to dissection related to the venture catheter, i had to perform pci to the proximal lad and circumflex with stents placed in a "v" configuration, which successfully opened 100% stenosis at the ostium of both vessels.Provider documented "distal left main dissection extending into ostium of the lad and circumflex post successful balloon angioplasty.The pt did have ventricular tachycardia, which was successfully treated with 1 shock at 200 joules to restore sinus rhythm.I spent approx 13 days in the intensive care unit, was on the vent twice.I feel had it not been for the defective venture cardiac catheter dissecting my heart arteries, i would have had to have less stents placed and my hosp stay lessened.Since then i have info the venture cardiac catheters owned by teleflex's (tfx) vascular solutions, inc have been recalled for defective tips.The lot number i was able to obtain for the defective venture catheter used on me was #580195.Fda safety report id# (b)(4).

• Brand Name: VENTURE CARDIAC CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC
• MDR Report Key: 9779879
• MDR Text Key: 182364193
• Report Number: MW5093481
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 580195
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 61