MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE MONORAIL PTCA DILATATION CATHETER; CATHETERS, TRANSLUMINAL, CORONARY, ANGIOPLASTY, PERCUTANEOUS

Model Number GTIN 08714729846451

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 02/14/2019

Event Type  Injury  

Event Description

Coronary balloon malfunction; rupture.Addressed with vendor at the time.

• Brand Name: NC EMERGE MONORAIL PTCA DILATATION CATHETER
• Type of Device: CATHETERS, TRANSLUMINAL, CORONARY, ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8394139
• MDR Text Key: 138065025
• Report Number: MW5084667
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GTIN 08714729846451
• Device Catalogue Number: H7493926712500
• Device Lot Number: 20813263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR