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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493926708320
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that tip detachment occurred.After a stent was placed, a 3.25mm x 8mm nc emerge® balloon catheter was advanced for post-dilation.However, it was noted that the balloon tip broke off.The broken pieces were retrieved and the procedure was completed.No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that the target lesion was 90% stenosed, located in the heavily calcified with non-serious tortuosity right coronary artery.The 3.25mm x 8mm nc emerge balloon catheter was trying to cross the lesion and was never inflated when the shaft broke.The guide wire, guide extension catheter, and guide catheter were removed and everything came out without snaring.
 
Event Description
It was further reported that the target lesion was 90% stenosed, located in the heavily calcified with non-serious tortuosity right coronary artery.The 3.25mm x 8mm nc emerge balloon catheter was trying to cross the lesion and was never inflated when the shaft broke.The guide wire, guide extension catheter, and guide catheter were removed and everything came out without snaring.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter in two pieces.The balloon was loosely folded with blood in the lumen and balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 70.7cm from the hub.The fracture faces were oval as if kinked prior to separation.There are numerous hypotube and shaft kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
 
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Brand Name
NC EMERGE®
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
MDR Report Key7621778
MDR Text Key111899980
Report Number2134265-2018-05367
Device Sequence Number1
Product Code LOX
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,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/16/2020
Device Model NumberH7493926708320
Device Catalogue Number39267-0832
Device Lot Number0021998555
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Date Manufacturer Received07/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age81 YR
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