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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493927615300
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event : 18 years or older. (b)(4).
 
Event Description
It was reported that balloon rupture occurred. The 90% stenosed target lesion was located in the severely calcified coronary artery. A 3. 00mm x15mm nc emerge® balloon catheter was advanced for dilation. When the balloon was inflated below nominal pressure, the balloon ruptured. The device was completely removed from the patient's body. The procedure was completed using with a different device. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter. The balloon was loosely folded with contrast and blood in the balloon and lumen. There was blood in the wire lumen. There were numerous hypotube kinks. The balloon, markerbands, proximal bond and tip were microscopically examined. A longitudinal tear was identified in the balloon wall. Microscopic examination of the balloon presented no irregularities in the balloon material, markerband and proximal bond that could have contributed to the damage. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
 
Event Description
It was reported that balloon rupture occurred. The 90% stenosed target lesion was located in the severely calcified coronary artery. A 3. 00mm x15mm nc emerge® balloon catheter was advanced for dilation. When the balloon was inflated below nominal pressure, the balloon ruptured. The device was completely removed from the patient's body. The procedure was completed using with a different device. No patient complications were reported.
 
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Brand NameNC EMERGE®
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 Key6190680
MDR Text Key62915148
Report Number2134265-2016-12063
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Model NumberH7493927615300
Device Catalogue Number39276-1530
Device Lot Number19748256
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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