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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 Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Device evaluated by mfr. : the returned product consisted of an nc emerge mr balloon catheter. The device was visually and microscopically examined. There was a separation of the hypotube 28. 6cm from the strain relief. The separated ends of the hypotube were ovaled in shape indicating the device was kinked prior to separation. There was contrast in the inflation lumen and blood in the guidewire lumen. The balloon was loosely folded.
 
Event Description
Reportable based on device analysis completed on 23sep2021. It was reported that shaft kink occurred. The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery. A 3. 00mm x 12mm nc emerge balloon catheter was advanced for dilation. During the procedure, it was noted that the shaft was kinked. The procedure was completed with another of same device. There were no patient complications nor injuries reported. However, returned device analysis revealed a separation of the hypotube.
 
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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 Key12591807
MDR Text Key275430479
Report Number2134265-2021-12479
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 10/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0026284602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2020
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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