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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 an encore inflation device was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noticed that the needle of the pressure gauge was stuck at 4 atm and would not moved.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 okay.
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 on (b)(6) 2021.During the procedure, it was noticed that the needle of the pressure gauge was stuck at 4 atm and would not moved.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 okay.
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: device code a0902 captures the reportable issue of the gauge reading inaccurately.Block h10: investigation results: a visual examination of the returned complaint device found that the gauge needle was at 4 atm when received.Functional evaluation was then performed to evaluate if the device could meet required specifications.A pressure damping test was performed to ensure the unit falls from 13 atm to 0 atm within 1 second, the device failed as the gauge needle returned to 4 atm after lock button was released.A vacuum test was performed by priming the unit with 5 ml of water before withdrawing the plunger to create a vacuum; there was no bubble leakage found, but the gauge needle was not able to reach the vacuum indicator in the gauge.A side load test was performed where weight was applied to the handle, but the gauge needle was not able to reach the vacuum indicator in the gauge.A gauge accuracy test was performed at 0 atm, 13 atm, and 26 atm, and the device accuracy failed at 13 atm and 26 atm.A device locking mechanism test was performed and the plunger handle was rotated to achieve 26 atm; this test is repeated 20 times consecutively and no issues were noted.In sum, the device failed the overall functional test, which confirms the reported event.This problem is likely due to factors encountered during the procedure, such as the way in which the device was handled during the procedure or the gauge itself receiving damage or an impact, leading to the problem of gauge reading inaccurately.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 11594942
• Report Number: 3005099803-2021-01288
• Device Sequence Number: 19889903
• Product Code: MAV
• UDI-Device Identifier: 08714729755241
• UDI-Public: 08714729755241
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K955869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 10/23/2023
• Device Model Number: M00566670
• Device Catalogue Number: 6667
• Device Lot Number: 0026238508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/10/2021
• Patient Sequence Number: 1