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

Model Number	M00553200
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was attempted to be used in the esophagus during an esophageal stricture dilation procedure performed on (b)(6) 2024.During the procedure, it was reported that the device was unable to maintain the pressure.The procedure was not completed due to this event as an alternative device was not available.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h11: the returned pneumatic inflator was analyzed, and a visual evaluation noted that no problem was noted with the gauge or the hand pump.Functional evaluation noted that when actuating the hand pump, it was able to inflate the balloon.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of device failure to inflate was not confirmed.Upon analysis, it was found that no problem was noted with the gauge or the hand pump.The hand pump and was actuated and the device was able to inflate the balloon.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.Therefore, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was attempted to be used in the esophagus during an esophageal stricture dilation procedure performed on (b)(6) 2024.During the procedure, it was reported that the device was unable to maintain the pressure.The procedure was not completed due to this event as an alternative device was not available.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 CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19454128
• Report Number: 3005099803-2024-02528
• Device Sequence Number: 8611630
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: 08714729195450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 10/08/2024

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: 0030090599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 10/08/2024
• 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