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	11/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result a visual examination of the returned complaint device found that the needle was on the back side of the stop pin.The needle was removed and reset within zero range, it was attempted to inflate to 20 psi but the needle did not move.There were finger prints and a residue inside of the lens which indicated that the unit was damaged during cleaning, resulting in an internal movement break.The reported event was confirmed.The device problem is likely to happen during cleaning which were traced to improper routine or preventive maintenance.Therefore, the most probable root cause is cause traced to maintenance.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was used in the esophagus during pneumatic dilation procedure performed on (b)(6) 2021.During the procedure, it noted that the device did not had the pressure.The procedure was completed with another pneumatic inflator device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of gauge reading inaccurate.

• 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: 14493215
• Report Number: 3005099803-2022-02908
• Device Sequence Number: 5798975
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: 08714729195450
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/24/2022

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: 0027282068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 78 KG