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

Model Number	M00553200
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2022 as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator device was used in the cardia during a gastrointestinal dilatation procedure performed on an unknown date.During the procedure, it was noted that the pneumatic pump gauge stopped working after the second use.The procedure was completed without the use of this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6)2022 as no event date was reported.Block h6: device code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation result a visual examination of the returned complaint device found that the needle was on the back side of the stop pin and it was noted to be loose.The inflator was hooked up to a test gauge and was attempted to be inflated with no success.A damage was noticed in the inner gears.The unit was disassembled and a movement break was found out which was possibly done during cleaning.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 device was used in the cardia during a gastrointestinal dilatation procedure performed on an unknown date.During the procedure, it was noted that the pneumatic pump gauge stopped working after the second use.The procedure was completed without the use of this 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 device was used in the cardia during a gastrointestinal dilatation procedure performed on an unknown date.During the procedure, it was noted that the pneumatic pump gauge stopped working after the second use.The procedure was completed without the use of this device.There were no patient complications reported as a result of this event.Correction noted on july 12, 2023.During the procedure, it was noted that the pneumatic pump gauge stopped working.The procedure was completed at this time and did not require device replacement.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to 03/01/2022 as no event date was reported.Block h6: device code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation result- a visual examination of the returned complaint device found that the needle was on the back side of the stop pin and it was noted to be loose.The inflator was hooked up to a test gauge and was attempted to be inflated with no success.A damage was noticed in the inner gears.The unit was disassembled and a movement break was found out which was possibly done during cleaning.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.Block h11: correction: block b5 (describe event or problem) has been corrected.

• 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: 14044754
• Report Number: 3005099803-2022-01842
• Device Sequence Number: 14673630
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2023

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: 0026770030
• 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: 03/17/2022
• Supplement Date Received by Manufacturer: 04/29/2022; 07/12/2023
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/20/2022; 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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 Sex: Unknown