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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 Deflation Problem (1149)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address (b)(6).
 
Event Description
It was reported that balloon deflation failure occurred.A 5.50mm x 8mm nc emerge balloon catheter was advanced for dilatation.The balloon was inflated at 16 atmospheres; however, the balloon would not deflate and had to be removed inflated and intact.No patient complications were reported and the patient was in good condition.
 
Manufacturer Narrative
E1 initial reporter address 1: (b)(6).Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 124.1cm distal of the strain relief.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.The outer shaft was stretched down for 92mm starting at the end of the hypotube and extending distally.The inner shaft was separated from the tip.The inner was buckled 60mm from the tip.A guidewire was stuck in the distal portion of the device.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that balloon deflation failure occurred.A 5.50mm x 8mm nc emerge balloon catheter was advanced for dilatation.The balloon was inflated at 16 atmospheres; however, the balloon would not deflate and had to be removed inflated and intact.No patient complications were reported and the patient was in good condition.
 
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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
MDR Report Key10628673
MDR Text Key209833678
Report Number2134265-2020-13308
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/24/2021
Device Model Number7311
Device Catalogue Number7311
Device Lot Number0023692205
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Initial Date Manufacturer Received 09/15/2020
Initial Date FDA Received10/05/2020
Supplement Dates Manufacturer Received11/10/2020
Supplement Dates FDA Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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