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

Model Number M00550601

Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used in the duodenal papillary orifice during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the pressure gauge could not be used as normal.The customer reported that the balloon was able to be inflated however, the pressure gauge would not move.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 at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a0902 captures the reportable event of reading inaccurate.

Manufacturer Narrative

Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation results the returned alliance inflation syringe was analyzed, and a visual examination found no damages to the device.Functional analysis was performed, the syringe was pressurized without problem, however, the gauge did not read the pressure.The gauge was damaged.Microscopic inspection found that the included irrigation tube is blocked.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.The results of the analysis performed on the returned device showed that the gauge did not read the pressure.It is possible that during the procedure, the device has faced a hit to the meter, which has caused the problem of reading the pressure, perhaps the manipulation, technique used could have contributed to this event.Therefore, the most probable root cause is an adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used in the duodenal papillary orifice during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the pressure gauge could not be used as normal.The customer reported that the balloon was able to be inflated however, the pressure gauge would not move.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 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18069516
• MDR Text Key: 327329451
• Report Number: 3005099803-2023-05914
• 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: 12/14/2023

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: 01/05/2024
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0028628108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 11/23/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 71 KG