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

Model Number	M00550620
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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
It was reported to boston scientific corporation that an alliance handle was used during a sphincteroplasty procedure performed in the common bile duct (cbd) on (b)(6) 2021.During the procedure, while inflating the cre balloon it was noticed that there was a slight resistance in the handle.The spring came out of the handle.The procedure was not completed and the patient was sent to a different hospital.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: impact code f1001 captures the reportable event of aborted/cancelled procedure.Block h10: investigation results the spring lever of the device fell out after being removed from the bag.It was also noted that the spring was not in its original shape and may have been caused by pumping the handle past the stop location and using force to do so.The shifter knob was turned to neutral position, it was noticed that the device would not move.Wear/internal damage and significant corrosion was noted due to being submerged in a cleaning substance.The alliance ii handle instructions for use (ifu) states: do not immerse the unit in disinfecting solutions.With all of the information available, bsc concludes that unintended inappropriate use of the device may have caused or contributed to the reported clinical observations.Therefore, the most probable root cause is unintended use error caused or contributed to event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that an alliance handle was used during a sphincteroplasty procedure performed in the common bile duct (cbd) on (b)(6) 2021.During the procedure, while inflating the cre balloon it was noticed that there was a slight resistance in the handle.The spring came out of the handle.The procedure was not completed and the patient was sent to a different hospital.There were no patient complications reported as a result of this event.

• 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): BOSTON SCIENTIFIC CORPORATION; 2 hampshire street suite 202; foxborough MA 02035
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12771189
• Report Number: 3005099803-2021-05765
• Device Sequence Number: 4595550
• Product Code: KNT
• UDI-Device Identifier: 08714729283881
• UDI-Public: 08714729283881
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K860589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown