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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 Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. Device evaluated by mfr. : the device was returned for analysis. The outer shaft, inner shaft, balloon and tip were visually and microscopically examined. Visual examination revealed a longitudinal tear in the inflation lumen and guidewire lumen 23. 6cm from the tip and approximately 1cm long. Microscopic examination revealed that the tip is damaged. The guidewire lumen is buckled 3. 1cm from the tip for approximately 1. 8cm and 5. 1cm from the tip for approximately 1. 4cm. There is contrast present in the inflation lumen and balloon. The balloon is loosely folded. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis confirmed there is a longitudinal tear in the inflation lumen and guidewire lumen.
 
Event Description
It was reported that shaft hole occurred. The target lesion was located in the left main trunk to left anterior descending artery. A 5. 50mm x 12mm nc emerge balloon catheter was advanced for post-dilation. However, during third inflation, the air got inside the indeflator. A negative pressure was not applied during rewrapping. When the shaft was checked, it was confirmed that there was a hole in the shaft. The device was removed from the patient's body. The procedure was completed with another of the same device. No patient serious injury or adverse event were reported.
 
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Brand NameNC EMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8326204
MDR Text Key135734702
Report Number2134265-2019-00918
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/17/2020
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0022667211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/11/2019 Patient Sequence Number: 1
Treatment
INFLATION DEVICE: ENCORE BSJ; STENT: RESOLUTE ONYS MEDTRONIC
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