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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 39189-1525
Device Problems Communication or Transmission Problem (2896); Device Markings/Labelling Problem (2911); Incorrect Device Or Component Shipped (2962)
Patient Problem Rupture (2208)
Event Date 12/21/2013
Event Type  Injury  
Event Description
During a procedure, one of our physicians requested an emerge 2.5mm x 15mm (39189-1525) balloon.The staff thought he said an emerge 3.5mm x 15mm (39189-1535).The emerge 3.5mm balloon was introduced into a circumflex artery.Once the balloon was inflated, the artery ruptured requiring the patient to receive emergency coronary artery bypass.The patient survived the surgery, but had further complications post surgery.It was felt that the event was caused by the mis-communication of the product size but the labeling of the product was so small that it was not identified visually by the physician that it was the incorrect product.
 
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Brand Name
EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC
one boston scientific place
natick MA 01760 153
MDR Report Key3758555
MDR Text Key16086869
Report Number3758555
Device Sequence Number1
Product Code LOX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model Number39189-1525
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/04/2014
Event Location Hospital
Date Report to Manufacturer04/18/2014
Patient Sequence Number1
Treatment
NOT IDENTIFIED VISUALLY BY THE PHYSICIAN THAT IT; IT WAS FELT THAT THE EVENT WAS CAUSED BY THE; MIS-COMMUNICATION OF THE PRODUCT SIZE BUT THE; WAS THE INCORRECT PRODUCT.; LABELING OF THE PRODUCT WAS SO SMALL THAT IT WAS
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age83 YR
Patient Weight72
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