Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 - CORK 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 - CORK ALLIANCE¿ II; SYRINGE, BALLOON INFLATION Back to Search Results
Model Number M00550601
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/29/2016
Event Type  malfunction  
Manufacturer Narrative
(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 an esophageal dilatation procedure performed on (b)(6) 2016.According to the complainant, during preparation, the gauge of the device was noted to be fogged up and unclear, making it difficult to read the pressure of the balloon.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be good.
 
Manufacturer Narrative
Investigation results.A visual examination of the complaint device revealed that the gauge cover was cloudy.The needle of the gauge was noted to be at 0 atm.A functional examination was performed and there were no visible issues noted.The complaint was most likely caused by handling of the device without patient contact either during the clinical procedure or unpacking/preparation of the device.Therefore, the most probable root cause is handling damage.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 directions for use (dfu)/product label.(b)(4).
 
Event Description
It was reported to boston scientific corporation that an alliance inflation syringe was used during an esophageal dilatation procedure performed on (b)(6) 2016.According to the complainant, during preparation, the gauge of the device was noted to be fogged up and unclear, making it difficult to read the pressure of the balloon.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be good.
 
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 - CORK
business and technology park
model farm road
cork
EI 
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI  
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key5815625
MDR Text Key50220044
Report Number3005099803-2016-02138
Device Sequence Number1
Product Code MAV
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/01/2016
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 Date03/21/2018
Device Model NumberM00550601
Device Catalogue Number5060-05
Device Lot Number0019056593
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/01/2016
Initial Date FDA Received07/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-