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	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: 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 the gastroesophageal (ge) junction during an esophagogastroduodenoscopy (egd) with dilation procedure performed on (b)(6) 2024.During the procedure, the pump was functional, but the dial did not move.The customer reported that the balloon was able to be inflated with the pump but, the gauge was not reading accurately.The procedure was able to be completed successfully with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation results: the returned pneumatic inflator was analyzed, and a visual inspection found no damage or defect with the gauge or the hand pump.Functional assessment was conducted by attaching a rigiflex ii balloon to the device and actuating the hand pump to attempt to inflate.The balloon was able to inflate.The pressure gauge needle on the device did move and was able to hold its position for at least 10 seconds, indicating the device was holding pressure and functioning properly.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of gauge reading inaccurate was not confirmed.The results of the analysis performed on the returned device found that the device was able to hold pressure and inflate a balloon.No problems were noted with the pressure gauge needle as it was able to move and hold its position when the hand pump was actuated.Therefore, the most probable root cause is no problem detected.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was used in the gastroesophageal (ge) junction during an esophagogastroduodenoscopy (egd) with dilation procedure performed on (b)(6) 2024.During the procedure, the pump was functional, but the dial did not move.The customer reported that the balloon was able to be inflated with the pump but, the gauge was not reading accurately.The procedure was able to be completed successfully with the original device.There were no patient complications reported as a result of this event.

• 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 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: 18615044
• Report Number: 3005099803-2024-00202
• Device Sequence Number: 15323145
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: 08714729195450
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown