MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26; SYRINGE, BALLOON INFLATION

Model Number	M00566670
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the returned complaint device revealed that the device did not have any visual defects.The gauge needle was at 0 atm when received.Functional evaluation was performed, and the device was pressurized at 26 atm for 20 times consecutively; there was no issues observed.A gauge accuracy test was performed at 0 atm, 13 atm, and 26 atm, and all tests passed.The reported event of the gauge reading inaccurately therefore cannot be confirmed.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is no problem detected since the device complaint or problem cannot be confirmed.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 an encore inflation device was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the ampulla of vater on (b)(6) 2020.According to the complainant, during the procedure, the gauge would not indicate the correct pressure applied to the balloon.The procedure was completed with another encore inflation device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ENCORE 26
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10563694
• Report Number: 3005099803-2020-03943
• Device Sequence Number: 2823194
• Product Code: MAV
• UDI-Device Identifier: 08714729755241
• UDI-Public: 08714729755241
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K955869
• 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
• Report Date (Section B): 09/21/2020

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 Expiration Date: 12/17/2022
• Device Model Number: M00566670
• Device Catalogue Number: 6667
• Device Lot Number: 0024952402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1