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

Model Number 3040

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

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 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
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10791216
• MDR Text Key: 214751246
• Report Number: 2134265-2020-14824
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1