FDA Adverse Event
Malfunction
Summary report: N
BOSTON SCIENTIFIC ENCORE 40 INFLATION DEVICE
MDR report key: 22901432
·
Received August 27, 2025
Report
- Report Number
- 2124215-2025-57355
- Event Type
- Malfunction
- Date Received
- August 27, 2025
- Date of Event
- August 1, 2025
- Report Date
- August 26, 2025
- Manufacturer
- ATRION MEDICAL PRODUCTS, INC.
- Product Code
- MAV
- UDI-DI
- 00856877002445
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D2B: PRO CODE (PRODUCT CODE): KOE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE GAUGE FAILED TO ZERO. AN ENCORE 40 INFLATION DEVICE WAS SELECTED FOR SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, THE PRESSURE WAS LOWERED, BUT THE GAUGE DID NOT DROP TO ZERO. THE INDEFLATOR WAS REPLACED, AND THE BALLOON WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1404935 | BOSTON SCIENTIFIC ENCORE 40 INFLATION DEVICE | INFLATION DEVICE | MAV | ATRION MEDICAL PRODUCTS, INC. | M001394472540 | 0096505029 | 00856877002445 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |