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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7135
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/06/2020
Event Type  malfunction  
Event Description
It was reported that catheter entrapment occurred. The target lesion was located in a left coronary artery. After a 300cm non-bsc support guidewire crossed the lesion, a 4. 00mm x 30mm emerge balloon catheter was advanced for dilatation. However, during withdrawal, the balloon could not move without moving the wire. The procedure was completed with a different device. No patient complications nor injuries were reported.
 
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Brand NameEMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9889520
MDR Text Key185547374
Report Number2134265-2020-03780
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,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/10/2021
Device Model Number7135
Device Catalogue Number7135
Device Lot Number0023180988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2019
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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