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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 7212
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2019
Event Type  malfunction  
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 catheter entrapment occurred.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilation.However, it was noted that the device became entangled with the 300cm non-bsc wire.There were no patient complications nor injuries reported.
 
Event Description
It was reported that catheter entrapment occurred.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilation.However, it was noted that the device became entangled with the 300cm non-bsc wire.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: returned product consisted of a nc emerge balloon catheter with an unknown guide wire.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube is separated and the proximal section of the device is missing.Measuring from the tip of the device to the separation is approximately 49.2cm.The hub and the proximal section of the hypotube is missing.The hypotube is kinked 46.5cm from the tip.Microscopic examination revealed a kink to the inflation lumen and guide wire lumen 13.8cm from the tip.There is blood present on the balloon folds and the balloon is still tightly folded.The guide wire was visually inspected for damages and measured.The guide wire outside diameter measured at ~0.014" and the length measured just over 300cm long.There is a spiral section approximately 100cm from the distal end of the guide wire.The guide wire was inserted into the balloon and was able to go all the way thru.Some resistance was felt at the kink on the guide wire lumen.Inspection of the remainder of the device presented no other damage or irregularities.
 
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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 Key8417468
MDR Text Key138701231
Report Number2134265-2019-02321
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729846390
UDI-Public08714729846390
Combination Product (y/n)N
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/16/2020
Device Model Number7212
Device Catalogue Number7212
Device Lot Number23090550
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2019
Date Manufacturer Received03/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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