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

Model Number M00550601

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an alliance syringe was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the papilla was dilated; however, it was noticed that the pointer of the pressure gauge was inaccurate.The procedure was completed with another alliance syringe.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Block h6: device code a0902 captures the reportable event of the inflation device reading inaccurately.Block h10: investigation results: the returned alliance syringe was analyzed and a visual examination found that the device was returned without its extension tube.There were no visual defects noted on the device.The gauge needle was at 0 atm when received.Microscopic evaluation of the device revealed that the y connector had a fracture close to the connection between the syringe and the y connector.Functional inspection was attempted to pressurize the device at 10 atm with 35 ml of water; however, it was not possible due to a leak in the y connector.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of gauge reading inaccurate was confirmed as a leak was found and the device cannot hold stable pressure.The leak found in the y connector is likely to have occurred due to the manner in which the device was handled and manipulated.It is possible that excessive manipulation of the device without enough care could have induced the defect found.Therefore, the most probable root cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that an alliance syringe was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the papilla was dilated; however, it was noticed that the pointer of the pressure gauge was inaccurate.The procedure was completed with another alliance syringe.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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 Key: 16052151
• MDR Text Key: 308204691
• Report Number: 3005099803-2022-07607
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: 08714729129332
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K922573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

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 Date: 07/09/2023
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0027635338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 63 KG