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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION EMERGE MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493918920250
Device Problems Material Puncture/Hole (1504); Material Rupture (1546); Gas 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).
 
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Brand NameEMERGE MONORAIL
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
maple grove MN 55311
MDR Report Key11398499
MDR Text Key234482752
Report NumberMW5099711
Device Sequence Number1
Product Code LOX
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received03/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH7493918920250
Device Lot Number25043836
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: 03/01/2021 Patient Sequence Number: 1
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