• 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 - MAPLE GROVE 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 - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493918920300
Device Problem Material Rupture (1546)
Patient Problems Intimal Dissection (1333); Anemia (1706); Stroke/CVA (1770); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Cognitive Changes (2551)
Event Date 04/25/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr id: 2134265-2017-05706, 2134265-2017-05707, and 2134265-2017-05708. It was reported that balloon rupture, vessel dissection, myocardial infarction and frontal lobe infarction occurred. The target lesion was located in the left circumflex artery. A 3. 00mm x 20mm emerge¿ balloon catheter was advanced for dilatation. The balloon was inflated up to 11 atmospheres; however, the balloon did not hold pressure. Upon removal, the balloon was noted to be ruptured. Angiography was performed and revealed a moderate spiral dissection of the circumflex artery. Subsequently, a 2. 25mm x 28mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion. A 1. 5mm x 8mm emerge¿ push balloon catheter was then advanced to re-dilate the artery and a non-bsc guide wire was inserted. A 2. 25mm x 8mm promus premier¿ drug-eluting stent was then deployed. A 2. 25mm x 20mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion. This was followed by a 2. 5mm x 12mm promus premier¿ drug-eluting stent which was deployed successfully. Lastly, a 2. 25mm x 8mm rebel stent was deployed to complete the case. The patient experienced anemia requiring blood transfusion. The patient also suffered a right frontal parietal lobe infarct with subtle cognitive deficit. The patient remained pain free but did bump enzymes the following day. Eight days later, the patient was discharged.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEMERGE¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6596326
MDR Text Key76126554
Report Number2134265-2017-04952
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
Type of Report Initial
Report Date 05/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberH7493918920300
Device Catalogue Number39189-2030
Device Lot Number20296282
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 Received05/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/28/2017 Patient Sequence Number: 1
-
-