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

Model Number	M00553200
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0902 captures the reportable event of gauge reading inaccurate.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was used in a procedure performed on (b)(6) 2023.During the procedure, when inflating the manometer, the needle did not go up and down.The surgeon performed the dilation by incising on the manometer without precise measurement.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was used in a procedure performed on (b)(6), 2023.During the procedure, when inflating the manometer, the needle did not go up and down.The surgeon performed the dilation by incising on the manometer without precise measurement.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation results one pneumatic inflator device was returned, and a visual examination found that that the gauge needle was pointing straight down, below zero (0).No other defects were observed on the returned device.The inflator bulb was compressed repeatedly, and air pumped out of the tubing, however, the gauge needle remained stuck straight down.The pressure gauge was disassembled, and it was noted that the silver spring was detached from the white gear component.The spring was re-attached using tweezers.After repair, functional testing was performed by attaching a balloon and compressing the bulb.The gauge needle increased along with the pressure correctly and the balloon was inflated successfully and was held for approximately 10 seconds with no issues.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of gauge reading inaccurately was confirmed.Analysis of the returned device found the gauge needle on the pneumatic inflator did not move when the device was pumped.Disassembly of the pressure gauge identified detached internal components.Re-attaching the components resolved the pressure gauge problem the unit functioned as expected.No external damage was observed on the returned device.It is possible that the unit may have been dropped prior to use or the use over time resulted in the detached internal components.Based on all gathered information, the most probable cause of the reported event was determined to be cause traced to component failure, which indicates that the problems were traced to an expected or random component failure without any design or manufacturing issue.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• 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: 17501949
• Report Number: 3005099803-2023-04201
• Device Sequence Number: 2332194
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: 08714729195450
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 0030457764
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown