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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493918915250
Device Problems Kinked (1339); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 04/03/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: returned product consisted of an emerge balloon catheter. The balloon was tightly folded. There was contrast in the inflation lumen. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated 70 cm from the tip. The fracture faces were oval as if kinked prior to separation. There were numerous hypotube kinks. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).
 
Event Description
Reportable based on device analysis completed on 21-apr-2016. It was reported that shaft kink occurred. A 2. 50mm x 15mm emerge¿ balloon catheter was selected to dilate the lesion. However during preparation, the shaft was kinked. The device was not used and the procedure was completed with another of the same device. No patient complications were reported. However, returned device analysis revealed a hypotube break 70cm from the tip.
 
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Brand NameEMERGE¿
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 Key6555798
MDR Text Key74792934
Report Number2134265-2017-04451
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
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 04/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberH7493918915250
Device Catalogue Number39189-1525
Device Lot Number20256152
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2017
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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