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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 H7493927612270
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4).
 
Event Description
It was reported that sterility was compromised. During unpacking of a 2. 75 mm x 12 mm nc emerge® balloon catheter, it was noted that there was a dirt on the back of compliance chart in the sterile pouch. The device was used without issue and the procedure was completed. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc emerge compliance chart. The device and packaging was not returned for analysis. The packaging was examined. The compliance chart has a piece of foreign matter on the back side. The reported foreign matter was confirmed via product analysis; however it is inconclusive of when the fm appeared on the compliance chart as the package was returned opened. 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 sterility was compromised. During unpacking of a 2. 75mm x 12mm nc emerge balloon catheter, it was noted that there was a dirt on the back of compliance chart in the sterile pouch. The device was used without issue and the procedure was completed. 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 Key7742646
MDR Text Key115812440
Report Number2134265-2018-06950
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/22/2020
Device Model NumberH7493927612270
Device Catalogue Number39276-1227
Device Lot Number21640200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2018
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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