MAUDE Adverse Event Report: BOSTON SCIENTIFIC ATLANTAS; SR PRO 40 MHZ CORONARY CATHETER

Lot Number 18092419

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2016

Event Type  Injury  

Event Description

During a nstemi heart cath, the ivus catheter malfunctioned and pulled the stent back on itself.The catheter was unable to be removed from the pt's lad coronary artery.

• Brand Name: ATLANTAS
• Type of Device: SR PRO 40 MHZ CORONARY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; tifton GA 31794
• MDR Report Key: 7237756
• MDR Text Key: 98988542
• Report Number: MW5075017
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2018

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 Lot Number: 18092419
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization