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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 H7493927612350
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6). (b)(4).
 
Event Description
It was reported that balloon rupture occurred. The 80% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery (rca). A 3. 50mm x 12mm nc emerge balloon catheter was advanced for dilation. However, upon inflation at 20 atmospheres for 5 seconds, the balloon ruptured. No segment of the balloon was detached inside the patient after it ruptured. The procedure was completed with a different device. No patient complications were reported and the patient's status was good.
 
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 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. There is no indication the device was inflated over rated burst pressure. 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 80% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery (rca). A 3. 50mm x 12mm nc emerge® balloon catheter was advanced for dilation. However, upon inflation at 20 atmospheres for 5 seconds, the balloon ruptured. No segment of the balloon was detached inside the patient after it ruptured. The procedure was completed with a different device. No patient complications were reported and the patient's status was good.
 
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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 Key6191469
MDR Text Key62906568
Report Number2134265-2016-11814
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/05/2016
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 Date08/31/2018
Device Model NumberH7493927612350
Device Catalogue Number39276-1235
Device Lot Number19637961
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2016
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 Manufactured08/26/2016
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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