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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 7164
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 06/17/2019
Event Type  malfunction  
Event Description
It was reported that shaft break occurred. During preparation of a 3. 00mm x 20mm emerge balloon catheter, it was noted that the shaft was kinked and when it was touched it broke off. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.
 
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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 IRELAND LIMITED
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8773942
MDR Text Key150569632
Report Number2134265-2019-08007
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model Number7164
Device Catalogue Number7164
Device Lot Number0023026526
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2018
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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