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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2020
Event Type  malfunction  
Event Description
It was reported that the balloon ruptured. A 1. 5mm rotapro and rotawire were selected for use in a complex percutaneous coronary intervention (pci) procedure. The target lesion was located from the left main coronary artery to the proximal mid circumflex artery. A choice pt guidewire was initially attempted to wire the lesion followed by a non-bsc wire and fighter wire. A non-bsc device was used to exchange the guidewire to a rotawire once access was obtained four passes with the 1. 50mm rotapro burr were made from the left main coronary artery to the mid circumflex without complication. After angiographic review, the vessel appeared open with mild slow flow but no obvious dissection. The patient then experienced pain, and hemodynamic changes occurred. Blood pressure dropped and medication was given. A trapper device was used to assist in removal of a non-bsc catheter. Access to the vessel was lost and blood was noted within the trapper balloon at the end of the case and the balloon would not hold pressure. The vessel was re-wired without difficulty. Cpr was in progress by this time. A 2. 5x20 emerge was inserted and inflated. Cpr continued and at the time the patient was intubated. The circumflex was ballooned in mid and proximal, but the balloon ruptured. A 2. 75x20 balloon was inserted and inflated in the proximal circumflex. Angiography was performed. A 2. 75x38mm synergy stent was inserted in the mid circumflex. Patient cpr and code continued. The patient cardioverted from ventricle tachycardia (vt) and ventricle fibrillation (vf) throughout this time. A temporary pacemaker was inserted to attempt to gain a conducting rhythm. A second synergy stent was placed in proximal circumflex and left main artery. The patient continued to be unresponsive to cpr, the pacemaker, or medications and continued to have no pulse. All resuscitation efforts were stopped at this point.
 
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Brand NameEMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10268003
MDR Text Key199122840
Report Number2134265-2020-09165
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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