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

Model Number 3040

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/30/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced hypotension.An encore 26 inflation device was selected for use on the angioplasty of the left main artery.During the procedure, the inflation device had difficulty in inflating the balloon and releasing the stent.Then, when the balloon was finally inflated into the target lesion, the deflation button hardened and would not allow deflation.It had to be hit in order to respond.After hitting, the balloon was finally able to deflate and was completely removed.It was noted that the patient experienced transitory hypotension due to the deflation issue.No further complications were reported and the patient fully recovered after the procedure.

Manufacturer Narrative

The device was returned for analysis with the gauge needle at 0 atm when received.Visual inspection was performed and the device did not have visual defects.Functional testing of the complaint device was carried out to ensure that the unit met required specifications.The unit passed all functional tests without issues.No issues were identified during the product analysis.

Event Description

It was reported that the patient experienced hypotension.An encore 26 inflation device was selected for use on the angioplasty of the left main artery.During the procedure, the inflation device had difficulty in inflating the balloon and releasing the stent.Then, when the balloon was finally inflated into the target lesion, the deflation button hardened and would not allow deflation.It had to be hit in order to respond.After hitting, the balloon was finally able to deflate and was completely removed.It was noted that the patient experienced transitory hypotension due to the deflation issue.No further complications were reported and the patient fully recovered after the procedure.

• 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: 12182177
• MDR Text Key: 261985977
• Report Number: 2134265-2021-08820
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0026629880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other