• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALLIANCE II; SYRINGE, BALLOON INFLATION

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an alliance inflation syringe was used during an esophagogastroduodenoscopy (egd) procedure performed in the esophagus on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that the balloon was able to be successfully inflated; however, the gauge needle was stuck at zero.The procedure was able to be completed with this device.There were no patient complications reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALLIANCE II
Type of Device
SYRINGE, BALLOON INFLATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork
EI  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key11100919
MDR Text Key225325564
Report Number3005099803-2020-06435
Device Sequence Number1
Product Code MAV
UDI-Device Identifier08714729129332
UDI-Public08714729129332
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K922573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/31/2020
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 Date05/12/2022
Device Model NumberM00550601
Device Catalogue Number5060-05
Device Lot Number0025506765
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received12/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-