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

Model Number H7493918920250

Device Problems Material Puncture/Hole (1504); Material Rupture (1546); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2021

Event Type  Injury  

Event Description

Percutaneous transvenous dilatation catheter( balloon) was inserted into left ascending artery of heart.Left coronary angiogram begun, insufflator filled with contrast attached to catheter with contrast , pulling back of insufflator and then inflation begun for 11 seconds.Immediately air coming out of the side of catheter into the artery, balloon than ruptured, catheter removed, and aspirator catheter then inserted to remove air and blood clot.Post procedure review shows that catheter had hole in it as verified by interventionalist pushing contrast through the catheter and fluid and air were coming out of the side of the balloon.Fda safety report id# (b)(4).

• Brand Name: EMERGE MONORAIL
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; maple grove MN 55311
• MDR Report Key: 11398499
• MDR Text Key: 234482752
• Report Number: MW5099711
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 9024453401
• UDI-Public: 90244534-01
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2022
• Device Model Number: H7493918920250
• Device Lot Number: 25043836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2021
• 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; Life Threatening
• Patient Age: 52 YR
• Patient Weight: 82