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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493919320250
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 01/06/2017
Event Type  Injury  
Manufacturer Narrative
Age at time of event : 18 years or older. Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental med watch will be filed. (b)(4).
 
Event Description
It was reported that vessel dissection occurred. The target lesion was located in the distal anterior descending (lad) artery. The rotablation was performed successfully with no issues. Following rotablation, angiography was performed. Subsequently, a 2. 50mm x 20mm emerge¿ balloon catheter was advanced to dilate the lesion. Following balloon deflation, it was noted that a small dissection occurred. The dissection was successfully closed by deploying a covered stent. It was noted a synergy stent was deployed proximal to the covered stent. The case was completed and no further patient complications were reported. The patient was fine and stable.
 
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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 Key6245437
MDR Text Key64616356
Report Number2134265-2017-00249
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Model NumberH7493919320250
Device Catalogue Number39193-2025
Device Lot Number18965533
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 Received01/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2016
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: 01/12/2017 Patient Sequence Number: 1
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