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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 H7493926708350
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 11/25/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter. The balloon was loosely folded. The shaft is intact; there is no shaft separation. The outer shaft, inner shaft, balloon and tip were microscopically examined. There are numerous hypotube and shaft kinks. Inspection of the remainder of the device revealed no other damage or irregularities. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event. (b)(4).
 
Event Description
It was reported that shaft break occurred. During the preparation of a 3. 50mmx8mm nc emerge balloon catheter, it was noted immediately upon removing the device from the hoop that the shaft of the balloon was split. The procedure was completed with another of the same device. No patient complications were reported.
 
Manufacturer Narrative
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported that shaft break occurred. During the preparation of a 3. 50mmx8mm nc emerge balloon catheter, it was noted immediately upon removing the device from the hoop that the shaft of the balloon was split. 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 Key7121025
MDR Text Key247910293
Report Number2134265-2017-12278
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 11/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/03/2019
Device Model NumberH7493926708350
Device Catalogue Number39267-0835
Device Lot Number21333639
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2017
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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