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

Model Number	3040
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12182177
• Report Number: 2134265-2021-08820
• Device Sequence Number: 924783
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K955869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other