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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 H7493926715320
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 06/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter in two pieces. The shaft and hypotube were microscopically and visually examined. There was contrast in the inflation lumen and blood in the guidewire lumen and between the balloon folds. The balloon was tightly folded. Although it was reported that the device was not used in the patient, the presence of blood in the guidewire lumen and contrast media inflation lumen is indicative of handling beyond simply unpackaging the device, as was reported. There were numerous kinks throughout the hypotube of the device. There was a complete hypotube separation 66. 5cm from the strain relief. The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation. Inspection of the remainder of the device, apart from the observed damage, 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 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 shaft break occurred. A 3. 25mm x 15mm nc emerge® balloon catheter was selected for use. However, during unpacking, upon removing the device out from the hoop, it was noted that the mid shaft got separated. The procedure was completed with another of the same 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 Key6689898
MDR Text Key79176646
Report Number2134265-2017-06626
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberH7493926715320
Device Catalogue Number39267-1532
Device Lot Number19823370
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2016
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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