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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 Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 10/22/2019
Event Type  malfunction  
Event Description
It was reported that the package was not sealed up.During preparation of a 1.50mm x 12mm emerge balloon catheter, it was noticed that the bottom end of the package was opened.The device was not used and the procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a pouch for an emerge balloon catheter.The product pouch was visually inspected.The product pouch contained a unit and there had no bsc seal.The tyvek seal was inspected, and it was still intact.Inspection of the remainder of the packaging presented no other damage or irregularities.
 
Event Description
It was reported that the package was not sealed up.During preparation of a 1.50mm x 12mm emerge balloon catheter, it was noticed that the bottom end of the package was opened.The device was not used and the procedure was completed with another of the same device.No patient complications were reported.
 
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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 Key9306366
MDR Text Key170119975
Report Number2134265-2019-13430
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729806073
UDI-Public08714729806073
Combination Product (y/n)N
PMA/PMN Number
K121196
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7132
Device Catalogue Number7132
Device Lot Number0024177694
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Date Manufacturer Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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