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

Model Number	3040
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: visual inspection revealed that the gauge needle was at 0 atm when received.No visual defects were encountered in the device.Functional inspection revealed that a functional test of the complaint device was carried out using a bsc stopcock; the purpose of the analysis is to ensure that the unit meets the required specification.The flexcil line was easily attached to the stopcock.The unit was pressurized, however, the gauge was not reading, the needle remained in the position of 0 atm.No leaks nor damages in the device were noted.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2020.It was reported that the device kept on slipping off the delivery system.During angigram procedure, an encore 26 inflation device was selected for use and was screwed onto the stent delivery system.However, it kept on slipping off the delivery system and unable the action to be pulled to negative.The physician tried to do the same process couple of times but device kept on slipping off.It was replaced with another of the same device and used onto the same stent, which worked perfectly.There were no complications reported and the patient is in normal condition after the procedure.However, device investigation revealed that the gauge was not reading and the needle remained in the position of 0 atm though the unit was pressurized.

• Brand Name: ENCORE 26
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10791216
• Report Number: 2134265-2020-14824
• Device Sequence Number: 19094586
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 11/04/2020

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: 12/18/2021
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0024958575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1