• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493926720350
Device Problem Physical Resistance/Sticking (4012)
Patient Problems Death (1802); Rupture (2208); Loss Of Pulse (2562)
Event Date 05/06/2020
Event Type  Death  
Event Description
From staff: patient was in cardiac catheterization lab for cardiac intervention and stenting of the vein graft to obtuse marginal artery. Following the stent placement, the vein graft was post dilated with a 3. 5 x 20 mm nc emerge balloon. According to the physician report the balloon was not able to be retrieved from the vein graft when the rail was removed. Multiple interventions were tried to retrieve the balloon without success. Op report: the balloon was inflated to high pressure. After deflation the balloon could not be retracted easily but with guiding catheter repositioning and back tension, the balloon delivery catheter was able to be removed however, the balloon itself was retained within saphenous vein graft (svg). Wire position was also lost at that time. Reseating of the guide and angiography demonstrated rupture of the svg within the stented portion. A prowater was reintroduced into the vessel but could not be passed beyond the previously stented portion. A new 3. 5 mm balloon was introduced into the proximal vein graft to tamponade the bleed. Heparin was reversed with protamine. A 0. 014 x 180 cm prowater wire was placed across the lesion. Balloon angioplasty. A 3. 5 mm (d) x 20 mm (l), emerge balloon was employed. The balloon was placed across the lesion and given a single inflation with a maximum inflation pressure of 20 atm. The balloon was left inflated while the patient underwent cardiopulmonary resuscitation. Anesthesia was called and patient was intubated and placed on ventilator. The patient underwent several cycles of cpr and several rounds of epinephrine. Emergent venous access was obtained and levophed and dopamine were initiated. The patient developed pulseless electrical activity and had a resuscitation effort of 20 minutes. Time of death 1344.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNC EMERGE®
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10082637
MDR Text Key191843999
Report Number10082637
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493926720350
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/11/2020
Event Location Hospital
Date Report to Manufacturer05/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/22/2020 Patient Sequence Number: 1
-
-