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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 7161
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an emerge mr balloon catheter. A visual examination revealed that a separation in the hypotube at 53. 8cm from the strain relief. The separated ends of the hypotube were oval shaped indicating that the device was kinked prior to separation. There were numerous bends to the hypotube. There was contrast in the inflation lumen and balloon. The balloon was tightly folded. During function test, the balloon was able to be inflated to rated burst pressure, as well as deflate with no issue. Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
Reportable based on device analysis completed on 27sep2021. It was reported that the balloon had a slow inflation. A 2. 00mm and 8mm emerge balloon was selected for use during a percutaneous coronary intervention (pci) procedure. During procedure, the balloon had a slow inflation. The device removed completely and the procedure was successfully completed with another balloon. There were no patient complications reported. However, device analysis revealed a hypotube separation.
 
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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
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12575609
MDR Text Key274707064
Report Number2134265-2021-12419
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7161
Device Catalogue Number7161
Device Lot Number0026996831
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2021
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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