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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 H7493918920350
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 04/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: returned product consisted of the emerge balloon catheter in two pieces. The hypotube and shaft were microscopically examined. There was contrast in the inflation lumen and balloon. The balloon was loosely folded. There were numerous kinks throughout the hypotube and there was a complete hypotube separation 61. 5cm from the strain relief. The hypotube fracture surface was ovaled, which suggests the device was kinked prior to separation. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. No other issues were identified during the product analysis. 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
It was reported that shaft break occurred. A 3. 50mm x 20mm emerge¿ balloon catheter was selected to dilate the lesion. During insertion onto the guide catheter, it was noted that the shaft had weakened and broke. The device never entered the patient and was removed from the guide catheter. The procedure was completed with another of the same device. No patient complications were reported.
 
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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 Key6568071
MDR Text Key75215488
Report Number2134265-2017-04766
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 04/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Model NumberH7493918920350
Device Catalogue Number39189-2035
Device Lot Number20048114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2016
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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