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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 M00550620
Medical Device Problem Codes Defective Device (2588); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/06/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device is disposed.If any further relevant information is received, a supplemental mdr will be filed.
 
Event or Problem Description
It was reported to boston scientific corporation that an alliance handle was unpacked on (b)(6) 2020.According to the complainant, during preparation, it was noticed that the metal seatbelt on the side of the device that holds the syringe in place broke off.Reportedly, the procedure was not completed due to this event, and the procedure was rescheduled.There were no patient complications reported as a result of this event.
 
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Brand Name
ALLIANCE II
Common Device Name
SYRINGE, BALLOON INFLATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10793517
Report Number3005099803-2020-05142
Device Sequence Number1126115
Product Code KNT
UDI-Device Identifier08714729283881
UDI-Public08714729283881
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K922573
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/05/2020
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
Operator of Device Health Professional
Device Model NumberM00550620
Device Catalogue Number5062
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/12/2020
Initial Report FDA Received Date11/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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