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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 M00550601
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and 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 was used in the esophagus during an esophagogastroduodenoscopy (egd) with dilation procedure performed on an unknown date.It was reported that upon opening the package, it was noted that the gauge was stuck at 4.5 atm.The procedure was completed with another alliance inflation syringe.There have been no patient complications reported as a result of this event, and the patient condition following the procedure was reported to be stable.
 
Event Description
It was reported to boston scientific corporation that an alliance inflation syringe was used in the esophagus during an esophagogastroduodenoscopy (egd) with dilation procedure performed on an unknown date.It was reported that upon opening the package, it was noted that the gauge was stuck at 4.5 atm.The procedure was completed with another alliance inflation syringe.There have been no patient complications reported as a result of this event, and the patient condition following the procedure was reported to be stable.
 
Manufacturer Narrative
Block b3: date of event: date of event was approximated to 01/01/2021 as no event date was reported.Block h6: problem code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation results: a visual examination of the returned complaint device does not have any visual defects.It was noticed that the gauge needle indicated 0 atm when received.Functional evaluation was performed, and the device was connected to the extension tube in the female luer.The device was pressurized to verify if the gauge was stuck in 4.5 atm.It was noted that the device was able to hold the pressure and returned to 0 atm.Based on the analysis performed and the information provided, the most probable root cause for the complaint event cannot be detected since the reported device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
 
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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 Key11334423
MDR Text Key232584799
Report Number3005099803-2021-00543
Device Sequence Number1
Product Code MAV
UDI-Device Identifier08714729129332
UDI-Public08714729129332
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 04/27/2021
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 Date10/21/2022
Device Model NumberM00550601
Device Catalogue Number5060-05
Device Lot Number0026223196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Initial Date Manufacturer Received 01/22/2021
Initial Date FDA Received02/16/2021
Supplement Dates Manufacturer Received03/30/2021
Supplement Dates FDA Received04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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