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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 H7493926712400
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 02/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a shaft break occurred. A 4. 00mm x 12mm nc emerge balloon catheter was selected for dilation. However, when the balloon was about to insert, the shaft broke in half approximately 80cm from the hub. The device was not used inside the patient. The procedure was completed with another 4. 00mm x 12mm emerge balloon catheter. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr. , eval summary attached, method codes, result codes, conclusion codes updated. Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter. There was contrast and blood in the inflation lumen. The balloon was loosely folded. The shaft and hypotube were examined. There were numerous hypotube kinks. The hypotube was fractured 76cm from the hub. The fracture faces were oval as if kinked prior to separation. The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact. (b)(4).
 
Event Description
It was reported that a shaft break occurred. A 4. 00mm x 12mm nc emerge® balloon catheter was selected for dilation. However, when the balloon was about to insert, the shaft broke in half approximately 80cm from the hub. The device was not used inside the patient. The procedure was completed with another 4. 00mm x 12mm emerge balloon catheter. 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 Key7362766
MDR Text Key103285685
Report Number2134265-2018-02149
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,Followup
Report Date 02/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberH7493926712400
Device Catalogue Number39267-1240
Device Lot Number20498023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2017
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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