MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BSCI EMERGE MONORAIL BALLOON CATH 20 MM X 3.01MM CORONARY BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Lot Number 27023934

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/28/2021

Event Type  malfunction  

Event Description

Patient was a coa/poss.During the case a balloon was stuck in rca.Multiple attempts to remove the balloon were made but unsuccessful.Dr.Made the decision to consult surgery to be on standby, so that he could apply enough pressure to remove the balloon as maybe needed.During removal a portion of the device remained in the patient.Fda safety report id # (b)(4).

• Brand Name: BSCI EMERGE MONORAIL BALLOON CATH 20 MM X 3.01MM CORONARY BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 11946293
• MDR Text Key: 254913491
• Report Number: MW5101717
• Device Sequence Number: 1
• Product Code: LOX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 27023934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 47 YR
• Patient Weight: 98