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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 H7493919320300
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem ST Segment Elevation (2059)
Event Date 05/03/2018
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr. : it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed.   (b)(4).
 
Event Description
Same case as mdr id: 2134265-2018-04545 and 2134265-2018-04546. It was reported that st elevation occurred. The target lesion was located in the proximal to the mid right coronary artery. After rotablation was performed, a non-bsc guide wire crossed the lesion and a 3. 00mm x 20mm emerge¿ balloon catheter was advanced for dilatation. On inflation of the balloon, st elevations were noted in the avl (augmented voltage left arm) lead. Upon deployment of a 3. 0 x 8 synergy stent, more general st elevations were noted, as well as slow flow in the artery. Atropine and adrenaline were initiated, along with a bolus of glyceryl trinitrate. A 3. 5 x 16 synergy stent was then deployed and post dilation was performed with a 4. 0 non-bsc non-compliant balloon catheter. Following post dilation, st elevation was resolved. The patient recovered well and stayed as an in-patient at the hospital. A second diagnostic catheterization was performed five days later to follow-up and the stents are well deployed and flow issues fully resolved.
 
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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 Key7498041
MDR Text Key107708181
Report Number2134265-2018-04544
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 05/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/13/2020
Device Model NumberH7493919320300
Device Catalogue Number39193-2030
Device Lot Number21399981
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 Received05/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2017
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: 05/09/2018 Patient Sequence Number: 1
Treatment
ABBOTT WIGGLE WIRE
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