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

Model Number 25335

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2022

Event Type  malfunction  

Event Description

It was reported that the gauge did not reach zero.The 100% stenosed target lesion was located in the non tortuous and moderately calcified radial vein.An encore 26 inflation device was selected for use.During the procedure, the balloon was deflated.However, it was noted that the needle in the gauge did not reach zero.The procedure was completed with this device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the gauge needle was at 22 atm when received.Unit returns with an unknown stopcock attached.Functional inspection revealed that the unit falls from 13 atm to 0 atm within 1 second.Assuming that the 22 atm its 0 atm, pressure was increased to 6 atm (needle does not remain stable since it looks to decrease by itself) and returns to 22 atm.In another attempt unit returned to 16atms.The unit was primed with 5 ml of water before withdrawing the plunger to create a vacuum: assuming 16 atm its 0 atm.There was no bubble leakage.The unit passed side load testing.The device locking mechanism test was performed.This is where the plunger handle is rotated to achieve 26 atms and this test is repeated 20 times consecutively.Considering the 14 atm as the zero pressure was increased.Approximately: from 10 atm to 0 then returns to 9 atms from 9 atm to 0 then returns to 2 atms.After 2 attempts, the test is concluded as faulty.No other issues were identified during the product analysis.

Event Description

It was reported that the gauge did not reach zero.The 100% stenosed target lesion was located in the non tortuous and moderately calcified radial vein.An encore 26 inflation device was selected for use.During the procedure, the balloon was deflated.However, it was noted that the needle in the gauge did not reach zero.The procedure was completed with this device.No patient complications were reported.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15077751
• MDR Text Key: 296349545
• Report Number: 2124215-2022-26840
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: 08714729183624
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2024
• Device Model Number: 25335
• Device Catalogue Number: 25335
• Device Lot Number: 0029378127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• 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