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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 Consequences Or Impact To Patient (2199)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Initial reporter city:(b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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 was used during a gastrointestinal dilatation procedure performed on an unknown date.Though the event date is unknown, it was reported that this event occurred a few days prior to (b)(6) 2020.According to the complainant, during the procedure, it was noted that the gauge display did not move.The procedure was completed with another alliance inflation syringe.After the procedure, the device was tested and it was found that the needle just moved a little and returned immediately.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 was used during a gastrointestinal dilatation procedure performed on an unknown date.Though the event date is unknown, it was reported that this event occurred a few days prior to (b)(6) 2020.According to the complainant, during the procedure, it was noted that the gauge display did not move.The procedure was completed with another alliance inflation syringe.After the procedure, the device was tested and it was found that the needle just moved a little and returned immediately.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Block e1: initial reporter city: (b)(6).Block h6: problem code 1184 captures the reportable issue of gauge reading inaccurate.Block h10: investigation result: 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 pressurized using 35 ml of sterile water; no issues were noted with the gauge needle during analysis.As there was no issue with the visual and functional test during product analysis, the complaint incident cannot be confirmed.Taking into consideration the evaluation conducted and the details of the complaint, the most probable root cause of this event cannot be detected.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 Key10792514
MDR Text Key214789490
Report Number3005099803-2020-05071
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,foreig
Type of Report Initial,Followup
Report Date 12/02/2020
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 Date06/19/2022
Device Model NumberM00550601
Device Catalogue Number5060-05
Device Lot Number0025618346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2020
Initial Date Manufacturer Received 10/12/2020
Initial Date FDA Received11/05/2020
Supplement Dates Manufacturer Received11/05/2020
Supplement Dates FDA Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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