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

Model Number 3040

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 02/09/2023

Event Type  malfunction  

Event Description

It was reported that the gauge was showing incorrect pressure.An encore 26 inflation device was used to treat the arteriovenous fistula.During the procedure, it was noted that the gauge needle was not showing the proper/correct pressure.The balloon was inflated even though the pressure gauge needle did not move.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

The device was returned for evaluation.Visual inspection revealed that the gauge needle was at 0 atm when received and that the device did not have visual defects.Functional testing using a boston scientific stopcock was performed.The device fell from 13 atmospheres (atm) to 0 atm within 1 second and during vacuum testing, there was no bubble leakage.When a side load was applied to the proximal end of the handle, pressure was maintained.The gauge was tested at 13 atm, 26 atm, and 0 atm; the gauge read accurately for each.The plunger handle was rotated to achieve 26 atms, 20 times consecutively, and no issues were noted.A video provided by the client was viewed which indicated the gauge needle was not showing the proper/correct pressure.

Event Description

It was reported that the gauge was showing incorrect pressure.An encore 26 inflation device was used to treat the arteriovenous fistula.During the procedure, it was noted that the gauge needle was not showing the proper/correct pressure.The balloon was inflated even though the pressure gauge needle did not move.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16474026
• MDR Text Key: 310609303
• Report Number: 2124215-2023-08733
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 04/14/2023

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 Model Number: 3040
• Device Catalogue Number: 3040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: Asian