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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 7213
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2021
Event Type  malfunction  
Manufacturer Narrative
Device returned to manufacturer: the packaging, shaft, hypotube, tip and balloon were microscopically and visually examined. The device was received in a carton for batch 26757951. There was no pouch in the carton. The device was from batch 26757951. The device inspection found there were numerous kinks. There was contrast in the inflation lumen and balloon. The balloon was loosely folded. Microscopic inspection revealed tip damage. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis did not confirm the reported mislabeling as there was no pouch returned with the device.
 
Event Description
It was reported that a device had an incorrect label. A physician had requested a 3. 5 x 15mm nc emerge balloon catheter. The sealed box was labelled as 3. 5 x 15mm. The sealed inner pouch was labelled 4 x 8mm. The actual balloon was a 3. 5 x 15mm despite the labelling on the inner pouch. The device was used for the procedure, which was completed successfully with no patient injury.
 
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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 Key11613847
MDR Text Key254137470
Report Number2134265-2021-04297
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7213
Device Catalogue Number7213
Device Lot Number0026757951
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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