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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7163
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that a shaft break occurred.The target lesion was located in the left anterior descending artery (lad).A 1.50 mm x 15 mm emerge was used to dilate the lesion.The emerge balloon was deflated and removed.During washing of the device, the balloon shaft broke.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that a shaft break occurred.The target lesion was located in the left anterior descending artery (lad).A 1.50 mm x 15 mm emerge was used to dilate the lesion.The emerge balloon was deflated and removed.During washing of the device, the balloon shaft broke.No patient complications were reported in relation to this event.Device evaluated by mfr: returned product consisted of an emerge balloon catheter in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 64.9cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.
 
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Brand Name
EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key7997983
MDR Text Key124801437
Report Number2134265-2018-62076
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 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/17/2021
Device Model Number7163
Device Catalogue Number7163
Device Lot Number0022159653
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2018
Date Manufacturer Received11/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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