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

Model Number 25335

Device Problems Deflation Problem (1149); Display or Visual Feedback Problem (1184)

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

Event Date 03/29/2021

Event Type  malfunction  

Event Description

It was reported that the gauge reading was inaccurate.The 99% stenosed target lesion was located in the mildly tortuous and moderately calcified brachial shunt.An encore-26 was selected for use.During the procedure it was noted that the sterling balloon appeared to be dilated in fluoroscopy but the gauge needle only went up from 2atm-6atm.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the gauge needle was at 0 atm when received.The device does not have visual defects.A functional test of the complaint device was carried out using a bsc stopcock.The purpose is to ensure that the unit meets the required specification.A pressure damping test was performed and the unit passed the test.The vacuum test.The unit was primed with 5 ml of water before withdrawing the plunger to create a vacuum.There was no bubble leakage.The side load test involved applying a load of 3.5 +/- 0.1 kg to the proximal end of the handle.The unit pass if the unit maintains a vacuum in this position.The unit passes the test.The gauge accuracy test at 13 atm, 26 atm & 0 atm to assess the accuracy of the gauge under pressurization meet specification.The device locking mechanism test was performed.This is where the plunger handle is rotated to achieve 26 atm and this test is repeated 20 times consecutively.No issues were noted.The unit passed all functional tests without issues.

Event Description

It was reported that the gauge reading was inaccurate.The 99% stenosed target lesion was located in the mildly tortuous and moderately calcified brachial shunt.An encore-26 was selected for use.During the procedure it was noted that the sterling balloon appeared to be dilated in fluoroscopy but the gauge needle only went up from 2atm-6atm.The procedure was completed with another of same 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
• MDR Report Key: 11676299
• MDR Text Key: 245796080
• Report Number: 2134265-2021-04943
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: 08714729183624
• Combination Product (y/n): N
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2022
• Device Model Number: 25335
• Device Catalogue Number: 25335
• Device Lot Number: 0026358347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER - STERLING; BALLOON CATHETER - STERLING; BALLOON CATHETER - STERLING