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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7312
Device Problems Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2021
Event Type  malfunction  
Event Description
It was reported that removal difficulties were encountered. The target lesion was located in the moderately tortuous right coronary artery. A 6. 00mm x 12mm nc emerge balloon catheter was advanced for dilatation. However, resistance was felt when pulling the device out of the patient's body. After that, an attempt was made to reinsert the device again; however, it could not be inserted due to resistance with the guidewire. The procedure was completed with a different device. No patient complications were reported.
 
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Brand NameNC EMERGE
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 Key12274121
MDR Text Key264960953
Report Number2134265-2021-10001
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0026594217
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/04/2021 Patient Sequence Number: 1
Treatment
IMAGING CATHETER (TERUMO ALTAVIEW); INFLATION DEVICE (BSJ ENCORE)
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