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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALLIANCE II; SYRINGE, BALLOON INFLATION
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BOSTON SCIENTIFIC CORPORATION ALLIANCE II; SYRINGE, BALLOON INFLATION Back to Search Results
Model Number M00550600
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an alliance inflation syringe device was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.During the procedure, it was noted that the pressure in the gauge meter would not move at all even when pressure was applied.The device was removed and they started the procedure all over again by bringing the water back to the red line and prime the gun; however, the device would still not work.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that an alliance inflation syringe device was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.During the procedure, it was noted that the pressure in the gauge meter would not move at all even when pressure was applied.The device was removed and they started the procedure all over again by bringing the water back to the red line and prime the gun; however, the device would still not work.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: device code a0902 captures the reportable issue of the gauge reading inaccurately.Block h10: investigation results a visual examination of the returned complaint device revealed that the alliance syringe was returned without its extension tube.It was noted that the gauge needle indicated 0 atm.Functional evaluation was performed, and the device was pressurized using 35 ml of sterile water; no leak was observed.The device was able to hold the pressure but gauge was not indicating an accurate value, as the needle remained at 0 atm.Based on the available information, it is most probable that the manner in which the device was handled and manipulated may have caused the encountered problem, as applying excessive pressure to the device and/or excessive manipulation without enough care during the procedure could induce the problem found in this device.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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Brand Name
ALLIANCE II
Type of Device
SYRINGE, BALLOON INFLATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11963076
MDR Text Key255098408
Report Number3005099803-2021-02611
Device Sequence Number1
Product Code MAV
UDI-Device Identifier08714729746737
UDI-Public08714729746737
Combination Product (y/n)N
PMA/PMN Number
K922573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/08/2021
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 Date12/16/2022
Device Model NumberM00550600
Device Catalogue Number5060-05S
Device Lot Number0026527677
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2021
Initial Date Manufacturer Received 05/11/2021
Initial Date FDA Received06/08/2021
Supplement Dates Manufacturer Received06/14/2021
Supplement Dates FDA Received07/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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