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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 Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
Used (b)(6) 2019 as event date since the correct date was not provided. Device evaluated by mfr. : the device was returned for analysis. The outer shaft, inner shaft, balloon and tip were visually and microscopically examined. Visual examination revealed multiple kinks along the hypotube. Microscopic examination revealed that the tip is damaged. The guidewire lumen is stretched, prolapsed, and has a hole in it. All of the damage to the guidewire lumen is approximately 47mm from the tip. There is blood present in the guidewire lumen and the balloon is still tightly folded. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis found damage along the hypotube and on the guidewire lumen.
 
Event Description
Reportable based on device analysis completed on 22 jan 2019. It was reported that defective device occurred. A 2. 50mm x 15mm emerge balloon catheter was found to be defective. However, returned device analysis revealed shaft hole in material.
 
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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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8320992
MDR Text Key135566076
Report Number2134265-2019-00914
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Model Number7163
Device Catalogue Number7163
Device Lot Number0020040989
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2016
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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