MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALLIANCE II; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M00550620
Medical Device Problem Codes	Defective Device (2588); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the serial number.Therefore, the manufacture and expiration dates are unknown.(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 or Problem Description
Note: this report refers to one of two devices used in the same procedure.It was reported to boston scientific corporation that an alliance handle was used during a dilatation procedure performed on (b)(6) 2021.During the procedure, it was noticed that the handle was faulty.The procedure was not able to be completed as another spare handle was also faulty.No patient complications were reported as a result of this event.
Event or Problem Description
Note: this report refers to one of two devices used in the same procedure.It was reported to boston scientific corporation that an alliance handle was used during a dilatation procedure performed on (b)(6) 2021.During the procedure, it was noticed that the handle was faulty.The procedure was not able to be completed as another spare handle was also faulty.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the serial number.Therefore, the manufacture and expiration dates are unknown.Block h6: device code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results: a visual examination of the returned complaint device found that there were no defects detected related to the manufacturing/assembly.Functional evaluation was performed, the device was fully functional, with no problem or defects.Also, the device did show wear/internal damage, but nothing that affected the performance of the device.The problem found on the device may be related to factors such as patient condition and the inflation balloon that could contribute to the event; however, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause cannot be established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: ALLIANCE II
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): VIANT AS&O HOLDINGS LLC.; 45 lexington drive; laconia NH 03246
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12246339
• Report Number: 3005099803-2021-03794
• Device Sequence Number: 2796129
• Product Code: KNT
• UDI-Device Identifier: 08714729283881
• UDI-Public: 08714729283881
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K860589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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 Number: M00550620
• Device Catalogue Number: 5062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/04/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown