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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 7163
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/10/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of an emerge balloon catheter. The shaft, hypotube, tip and balloon were microscopically and visually examined. There was contrast and blood in the inflation lumen and in the balloon. Blood was present in the guidewire lumen. The balloon was loosely folded. The balloon had a pinhole 7mm proximal of the tip. The tip was damaged. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis confirmed the reported event that it was difficult to cross the lesion, as there was a pinhole in the balloon and tip damage.
 
Event Description
Reportable based on device analysis completed on 07-oct-2019. A 1. 50mm x 15mm emerge balloon catheter was returned without reported allegation. However, upon review of this device, a balloon pinhole was noted.
 
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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 Key9236639
MDR Text Key165436908
Report Number2134265-2019-12601
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 10/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/09/2021
Device Model Number7163
Device Catalogue Number7163
Device Lot Number0022924773
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2018
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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