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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10662
Device Problems Deflation Problem (1149); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2024
Event Type  malfunction  
Manufacturer Narrative
E1 initial reporter phone: (b)(6).
 
Event Description
It was reported that balloon deflation issues occurred.A 3.50 x 12mmpromus premier select stent balloon expandable was advanced for treatment.During the procedure a 3.50 x 12mmpromus premier select 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.
 
Event Description
It was reported that balloon deflation issues occurred.A 3.50 x 12mmpromus premier select stent balloon expandable was advanced for treatment.During the procedure a 3.50 x 12mmpromus premier select 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.
 
Manufacturer Narrative
E1 initial reporter phone: (b)(6).B5 describe event or problem: updated.
 
Event Description
It was reported that balloon deflation issues occurred.A 3.50 x 12mmpromus premier select stent balloon expandable was advanced for treatment.During the procedure a 3.50 x 12mmpromus premier select 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.
 
Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of the promus premier select stent delivery system (sds), batch #31542256.Visual, tactile, microscopic and functional analysis was performed on the device.Multiple kinks were noted along the hypotube shaft.Microscopic examination of the distal extrusion found that the inner/wire lumen was bunched at 5.5cm proximal from the tip of the device.In functional analysis, the device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure of 16 atmospheres with no leaks noted.However, when the device was deflated it took 20 seconds for the balloon to deflate.This inflate/deflate was repeated three more times and each deflation took approximately 20 seconds.Device analysis identified that the balloon deflated above the maximum deflation time specification (is less than equal to 16 seconds per the ifu).The average deflation time for the balloon during device analysis was 20 seconds.One possibility for the balloon deflating above its recommended deflation time is the fact there was damage on the inner wire lumen.E1 initial reporter phone: (b)(6).B5 describe event or problem: updated.
 
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Brand Name
PROMUS PREMIER SELECT
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 CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18640756
MDR Text Key334552885
Report Number2124215-2024-05682
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,Followup
Report Date 04/18/2024
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 Number10662
Device Catalogue Number10662
Device Lot Number0031542256
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2023
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; 6FR GUIDING CATHETER,MEDTRONIK AL
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