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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 H7493927608350
Device Problems Bent (1059); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: returned product consisted of the nc emerge balloon catheter. The balloon, tip, shafts, hypotube, and bonds were microscopically and visually examined. There was blood in the inflation lumen, guidewire lumen and balloon. The balloon was loosely folded. Microscopic examination presented no damage to the tip. There was an 11mm tear in the balloon wall from the proximal to distal ends of the balloon. Microscopic examination presented no irregularities in the balloon material or markerband that could have contributed to the balloon damage. Because there was no evidence of any product quality deficiencies, it was considered likely that the balloon burst was attributable to procedural factors. Inspection of the remainder of the device revealed no other damage or irregularities. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty. (b)(4).
 
Event Description
Reportable based on device analysis completed on 17-may-2017. It was reported advancing difficulties and tip damage occurred. The 75% stenosed target lesion was located in a severely tortuous and severely calcified mid right coronary artery (rca). A 3. 50mm x 8mm nc emerge® balloon catheter was advanced for pre-dilatation. However, during delivery of the device, advancing difficulties were encountered due to severe calcification in the proximal rca. When device was attempted to advance further, the tip of the device got kinked. The procedure was completed with a different device. No patient complications were reported. However, returned device analysis revealed longitudinal balloon tear.
 
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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 Key6613138
MDR Text Key76728055
Report Number2134265-2017-05445
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,distri
Reporter Occupation
Type of Report Initial
Report Date 05/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberH7493927608350
Device Catalogue Number39276-0835
Device Lot Number19825940
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2016
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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