MAUDE Adverse Event Report: BOSTON SCIENTIFIC NC EMERGE MONORAIL PCA DILATATION CATHETER

Catalog Number H7493926712250

Device Problems Difficult to Remove (1528); Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/04/2017

Event Type  Injury  

Event Description

A (b)(6) patient was undergoing a complex pci and a coronary balloon ruptured in the patient's coronary artery. Balloon became dislodged in the coronary artery. Md was able to snare the balloon and remove it from the coronary artery, however while proceeding down the aorta with the snared balloon, it became lodged in one of the patients abdominal arteries. The balloon location was verified under fluoroscopy imaging. Balloon fragments remain as a retained foreign object.

• Brand Name: NC EMERGE MONORAIL
• Type of Device: PCA DILATATION CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 6776728
• MDR Text Key: 82376250
• Report Number: MW5071448
• Device Sequence Number: 1
• Product Code: LIT
• 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: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/21/2019
• Device Catalogue Number: H7493926712250
• Device Lot Number: 20910503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 08/07/2017 Patient Sequence Number: 1