MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PNEUMATIC INFLATOR; CATHETER, BALLOON TYPE

Model Number	M00553200
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was attempted to be used during a dilatation procedure performed on an unknown date.During the procedure, the device was used in an attempt to inflate an achalasia balloon.The balloon did not inflate, and did not show any pressure change.The procedure was completed with another pneumatic inflator.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation findings of gauge reading inaccurate.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0902 captures the reportable investigation result of gauge reading inaccurate.Block h11: investigation results the returned pneumatic inflator was analyzed, and a visual inspection found that the gauge indicator pointing below zero.During functional testing, the inflator was able to inflate a balloon and maintain inflation, however, the indicator remained below zero.Upon disassembling the handle, it was observed that the spring had shifted from its original position and caused the indicator to point below zero.Once the device was repaired, the inflator read the pressure accurately while inflating the balloon.No other problems with the device were noted.The results of the analysis performed on the returned device found that the inflator was able to inflate a balloon and maintain inflation, however, the indicator remained below zero.Based on all gathered information, the probable cause code selected for the gauge reading inaccurate problem found is cause traced to component failure, which indicates that the problem is a random or expected problem of the device component, in this case the spring shifted from its position.

• Brand Name: PNEUMATIC INFLATOR
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21154568
• Report Number: 3005099803-2024-06911
• Device Sequence Number: 15750501
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: 08714729195450
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K781772
• 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
• Report Date (Section B): 01/14/2025

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: M00553200
• Device Catalogue Number: 5320
• Device Lot Number: 0030090599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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