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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 7311
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter name and address: (b)(6).
 
Event Description
It was reported that a pinhole damage on the shaft occurred. A 3. 50mm x 8mm nc emerge balloon catheter was advanced, however, during the procedure, a pinhole damage around the middle of the shaft has occurred. The device was removed and completed the procedure with another of the same device.
 
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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 Key12719669
MDR Text Key279037900
Report Number2134265-2021-13630
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,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7311
Device Catalogue Number7311
Device Lot Number0025788127
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 Received10/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2020
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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