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 Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the device batch number; therefore the manufacture date is unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was used during an achalasia dilatation procedure performed in the esophagus on (b)(6) 2019.According to the complainant, during preparation, the gauge needle of the device would not work and stayed at 0 atm.The procedure was completed with another pneumatic inflator.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 was used during an achalasia dilatation procedure performed in the esophagus on (b)(6) 2019.According to the complainant, during preparation, the gauge needle of the device would not work and stayed at 0 atm.The procedure was completed with another pneumatic inflator.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the device batch number; therefore the manufacture date is unknown.Block g1: mfr site email: (b)(6).Block h6: device code 1184 captures the reportable event of gauge reading inaccurately.Block h10: investigation results a visual examination of the returned complaint device found that the gauge needle was at the wrong side of the stop pin when received.Functional evaluation was performed, and the device was inflated to 20 psi.The device was able to inflate but inflates about 1.5 psi low.The device was then reset to zero and upon retesting, the device performed within specifications.The test was performed five additional times with the same results.This failure is most likely due to improper routine or preventative maintenance; therefore, the most probable root cause is cause traced to maintenance.A manufacturing batch record review was unable to be performed as the batch number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.

• Brand Name: PNEUMATIC INFLATOR
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8765636
• Report Number: 3005099803-2019-03384
• Device Sequence Number: 11380998
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: 08714729195450
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K781772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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: 07/31/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1