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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10677
Device Problems Deflation Problem (1149); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2024
Event Type  malfunction  
Event Description
It was reported that a balloon deflation issue occurred.A 3.50 x 38 mm promus elite stent balloon expandable was advanced for treatment.During the procedure a 3.50 x 38 mm promus elite stent was implanted.Following implantation, the delivery balloon was attempted to be deflated, however the balloon did not fully deflate.It was not possible to pull the balloon back in the 6fr guiding catheter.The catheter, wire and balloon were retrieved, and the procedure was completed successfully.There were no patient complications reported.
 
Manufacturer Narrative
E1 initial reporter telephone: (b)(6).
 
Manufacturer Narrative
E1 initial reporter telephone: (b)(6).B5 describe event or problem: updated.
 
Event Description
It was reported that a balloon deflation issue occurred.A 3.50 x 38 mm promus elite stent balloon expandable was advanced for treatment.During the procedure a 3.50 x 38 mm promus elite stent was implanted.Following implantation, the delivery balloon was attempted to be deflated, however the balloon did not fully deflate.It was not possible to pull the balloon back in the 6fr guiding catheter.The catheter, wire and balloon were retrieved, and the procedure was completed successfully.There were no patient complications reported.It was further reported that at least 20 seconds was allowed for the balloon to deflate before attempting to withdraw the device.
 
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Brand Name
PROMUS ELITE
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18642850
MDR Text Key334804711
Report Number2124215-2024-05683
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10677
Device Catalogue Number10677
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
6FR GUIDING CATHETER, MEDTRONIK AL; 6FR GUIDING CATHETER, MEDTRONIK AL
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