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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 Contamination (1120); Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2022
Event Type  malfunction  
Event Description
It was reported that froze on wire occurred and the sterility was compromised.A 3.25mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, the device was trapped on the guidewire.It was noted that the sterility of the device was compromised.There were no patient complications reported.
 
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that froze on wire occurred and the sterility was compromised.A 3.25mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, the device was trapped on the guidewire.It was noted that the sterility of the device was compromised.There were no patient complications reported.
 
Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by manufacturer: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.At 1.1cm from the strain relief, the hypotube of the device was kinked.There was blood and contrast in the inflation lumen.The rapid port exchange was damaged indicating an interaction with a guidewire.The proximal portion of the balloon was bunched approximately 6mm in length from the proximal waist of the balloon.At 9mm from the tip of the device, there was a 2mm longitudinal tear to the balloon which was loosely folded.The guidewire used in the procedure was not returned for analysis and functional testing.Instead, a 0.014-inch guidewire was used for the wire insertion test.The guidewire passed through device with no resistance or issues.The guidewire was inserted through the rapid port exchange and the tip of the device and encountered no difficulties.Product analysis did not confirm the reported froze on wire, because the guidewire passed through the device with no resistance or issues.Sterility was also a reported event and given the reported information to the complaint and the state of the returned device which shows use past preparation with no packaging or media provided for further review, this reported event could not be confirmed.
 
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Brand Name
NC EMERGE
Type of Device
CATHETERS, 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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14936771
MDR Text Key302768893
Report Number2134265-2022-07629
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/25/2023
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0027900897
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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