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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Perforation (2001)
Event Date 10/25/2018
Event Type  Death  
Manufacturer Narrative
Date of death: (b)(6) or (b)(6) 2018.
 
Event Description
It was reported that the patient experienced a vessel perforation and died.A 1.5mm rotalink burr, rotawire elite and wireclip torquer, synergy stent, and a 2.5mm emerge balloon were selected for a patient procedure.The cto was crossed with a non-bsc wire and a non-bsc catheter, and the medical personnel were unable to cross with anything else.Rotablation was performed with a 1.5 mm rotalink burr.The lesion was dilated with a 2.5mm emerge balloon and thereafter treated with a synergy drug-eluting stent of unknown size.Upon imaging performed post treatment, a perforation was noticed distal to the stent.A non-bsc stent graft system was attempted to be placed, but it was unable to cross to the area of need.An unspecified 2.5mm balloon was then used to tamponade the perforation, at which point the patient also coded.Multiple shocks were administered to the patient and the patient was revived.An non-bsc heart pump was then placed in the patient.Pericardiocentesis was performed and 1200cc of fluid was returned.The patient was taken to the cardiovascular intensive care unit in critical condition.After this, the patient was made a dnr ("do not resuscitate").The patient then died on (b)(6) 2018 or (b)(6) 2018.
 
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Brand Name
EMERGE
Type of Device
CATHETERS, 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
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8080904
MDR Text Key127455974
Report Number2134265-2018-62936
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/16/2018
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2018
Initial Date FDA Received11/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
2.8MM GRAFTMASTER STENT GRAFT; IMPELLA HEART PUMP; PILOT 200 WIRE; TURNPIKE LP CATHETER
Patient Outcome(s) Death; Required Intervention;
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