MAUDE Adverse Event Report: ABBOTT ABBOTT TREK DILATATION CATHETER VIPER

Model Number 287213-1

Device Problems Deflation Problem (1149); Inflation Problem (1310); Material Rupture (1546); Infusion or Flow Problem (2964)

Patient Problems Chest Pain (1776); ST Segment Elevation (2059)

Event Type  Injury  

Event Description

(b)(6) patient admitted (b)(6) 2016 for left heart catheterization.During the procedure, after pre-dilation of the balloon in the cx om svg, the balloon would only partially deflate despite multiple attempts of inflation and deflation.The filterwire was withdrawn into the descending aorta and the coronary balloon was intentionally ruptured with high atms, then the balloon could be withdrawn into the catheter and the procedure could continue.There was slow flow as a result that ultimately resolved after stenting, ic nitroglycerin, ic verapamil and integrilin bolus.As a result, the patient had st segment elevation, chest pain for the duration of the procedure and required iv nitroglycerin for bp control.The patient was admitted to the micu and discharged the next day.

• Brand Name: ABBOTT TREK DILATATION CATHETER VIPER
• Type of Device: ABBOTT TREK DILATATION CATHETER VIPER
• Manufacturer (Section D): ABBOTT ; abbott park IL
• MDR Report Key: 5454684
• MDR Text Key: 38871926
• Report Number: MW5060380
• Device Sequence Number: 1
• Product Code: LOX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 287213-1
• Device Lot Number: 50502G1
• Other Device ID Number: PN 1012276-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 90