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	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Imdrf impact code f05 is being used to capture the reportable event of rescheduled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was used in the esophagus during an achalasia dilation procedure performed on (b)(6) 2024.During the procedure, the pump indicator remained fixed even though the balloon was inflated.The customer reported that the balloon was able to be inflated with the pump but, the gauge was not reading accurately.The procedure was not completed and was canceled as another device was not available.The customer reported that the procedure was rescheduled and was successfully completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Imdrf impact code f05 is being used to capture the reportable event of rescheduled procedure.Block h11: investigation results the returned pneumatic inflator was analyzed, and a visual inspection found that the indicator was reading below zero.Functional inspection was performed and the handpump was able to inflate the balloon, however, the indicator remained reading below zero.Upon disassembling the inflator, it was observed that the spring shifted from its position which caused the indicator to point below zero.Once fixed, the indicator was pointing to zero.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 found that the spring shifted from its position which caused the indicator to point below zero.Once fixed, the indicator was pointing to zero.Therefore, the most probable root cause is cause traced to component failure.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was used in the esophagus during an achalasia dilation procedure performed on (b)(6) 2024.During the procedure, the pump indicator remained fixed even though the balloon was inflated.The customer reported that the balloon was able to be inflated with the pump but, the gauge was not reading accurately.The procedure was not completed and was canceled as another device was not available.The customer reported that the procedure was rescheduled and was successfully completed.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: 18645856
• Report Number: 3005099803-2024-00292
• Device Sequence Number: 8244936
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: 08714729195450
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 11/13/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male