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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 Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2020
Event Type  malfunction  
Manufacturer Narrative
The returned product consisted of an emerge balloon catheter. Microscopic and visual examination of the device identified numerous hypotube kinks. There was contrast in the inflation lumen and balloon, and blood within the guidewire lumen, consistent with use. The balloon was loosely folded. There was no damage observed with the hub, which would indicate a possible connection problem. The emerge balloon catheter was successfully connected to an inflation device, filled with water and connected to the inflation port to inflate the device. There was a pinhole noted 6mm distal to the proximal marker band. Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
Reportable based on device analysis completed on 05feb2021. It was reported that device to device incompatibility occurred during a percutaneous coronary intervention on a patient with coronary artery disease. While attempting to inflate a 3. 50mm x 20mm emerge balloon, the balloon disconnected from the luer. The connection was maintained by hand while another balloon (same model) was attached and the procedure was successfully completed. No patient complications were reported in relation to this event. However, device analysis identified a pinhole.
 
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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 Key11361294
MDR Text Key233049147
Report Number2134265-2021-02142
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeNL
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 02/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7164
Device Catalogue Number7164
Device Lot Number0026000560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2020
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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