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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 H7493926715250
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 02/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that device sterility was compromised. During unpacking of a 2. 50mm x 15mm nc emerge® balloon catheter, it was noted that the glued corner of the sterile packaging appeared to be lifted slightly. The device was not used. The procedure was completed with a different nc emerge® balloon catheter. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter. Device was returned without the pouch. The complaint device was received in plastic wrap of an unknown type, with the balloon tightly folded. Microscopic inspection found contrast in the shaft/lumen of the device. Microscopic and tactile inspection revealed numerous kinks in the hypotube. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause was unable to be determined. (b)(4).
 
Event Description
It was reported that device sterility was compromised. During unpacking of a 2. 50mm x 15mm nc emerge® balloon catheter, it was noted that the glued corner of the sterile packaging appeared to be lifted slightly. The device was not used. The procedure was completed with a different nc 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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5528669
MDR Text Key41236225
Report Number2134265-2016-02038
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 02/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2018
Device Model NumberH7493926715250
Device Catalogue Number39267-1525
Device Lot Number18842060
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2016
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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