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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 7132
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: used (b)(6) 2019 as the provided event date was (b)(6) 2019.
 
Event Description
It was reported via medwatch that a shaft break occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm emerge balloon catheter was selected for use.However, while advancing the device the balloon catheter snapped.No known patient complications were reported.
 
Event Description
It was reported via medwatch that a shaft break occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm emerge balloon catheter was selected for use.However, while advancing the device the balloon catheter snapped.No known patient complications were reported.It was further reported that the 80% stenosed target lesion was located in the severely tortuous and severely calcified ostial right coronary artery.The device broke after the monorail and was completely removed through a normal method.The procedure was completed with another 2.50mm x 12mm emerge balloon catheter and the patient did well.
 
Manufacturer Narrative
Date of event and describe event or problem updated.
 
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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 Key8479056
MDR Text Key140790735
Report Number2134265-2019-03348
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729806103
UDI-Public08714729806103
Combination Product (y/n)N
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/26/2019
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 Date09/19/2021
Device Model Number7132
Device Catalogue Number7132
Device Lot Number0023230211
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/12/2019
Initial Date FDA Received04/03/2019
Supplement Dates Manufacturer Received04/08/2019
Supplement Dates FDA Received04/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
Patient Weight72
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