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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 Problems Defective Device (2588); Device-Device Incompatibility (2919); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2023
Event Type  malfunction  
Event Description
It was reported that foreign material was observed on the device.Foreign material was detected on the tip of three nc emerge catheters.The procedure was completed with another same device.No patient complications occurred.
 
Event Description
It was reported that foreign material was observed on the device.Foreign material was detected on the tip of three nc emerge catheters.The procedure was completed with another same device.No patient complications occurred.It was further reported that there was a thickening of the catheter material at approximately 10-15 cm proximal to the balloon.The thickening blocked the catheter from being introduced through the hemostasis valve.There was no material on the catheter surface, and it could not be peeled off.It was described as an obvious, unusual catheter form.All three balloons showed the same thickening at the same location on the catheter.
 
Manufacturer Narrative
Device evaluated by mfr.The nc emerge balloon catheter was received for analysis.The device was microscopically and visually examined.No foreign material was observed on the device.There was contrast dye found in the inflation lumen and the balloon was loosely folded.There was thickening in the catheter material observed proximal to the balloon and measurements of the catheters midshaft bond found it out of specification.Although the hemostatic valve used in the procedure was not returned with the nc emerge device, engineers used a test hemostatic valve to perform functional testing with the returned nc emerge device.The balloon catheter was able to be inserted into the hemostatic valve and exit successfully, there was no resistance or issues encountered while advancing through the hemostatic valve.Functional testing of the device was unable to reproduce the reported difficulty advancing the catheter through the hemostatic valve.The balloon catheter was able to pass through the hemostatic valve successfully without resistance.
 
Event Description
It was reported that foreign material was observed on the device.Foreign material was detected on the tip of three nc emerge catheters.The procedure was completed with another same device.No patient complications occurred.It was further reported that it was not foreign material on the catheter, but rather a thickening of the catheter material at approximately 10-15 cm proximal to the balloon.The thickening blocked the catheter from being introduced through the hemostasis valve, and it could not be peeled off.It was described as an obvious, unusual catheter form.All three devices showed the same thickening at the same location on the catheter.
 
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Brand Name
NC EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
pmt 741 persiaran cassia selat
bandarcassia, pulau pinan 14110
MY   14110
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key16754760
MDR Text Key313497293
Report Number2124215-2023-18048
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 07/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7311
Device Catalogue Number7311
Device Lot Number0030472125
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2022
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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