FDA Adverse Event
Malfunction
Summary report: N
SWIFT BALLOON DILATOR
MDR report key: 17642474
·
Received August 29, 2023
Report
- Report Number
- 1220592-2023-00007
- Event Type
- Malfunction
- Date Received
- August 29, 2023
- Date of Event
- August 16, 2023
- Report Date
- August 29, 2023
- Manufacturer
- HOBBS MEDICAL, INC.
- Product Code
- KNQ
- PMA / PMN Number
- K834413
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
MODEL SOLD EXCLUSIVELY OUTSIDE US.
Description of Event or Problem · 0
ACCORDING TO THE INITIAL REPORTER, DURING THE ESOPHAGEAL DILATATION PROCEDURE THE BALLOON WOULD NOT HOLD AIR PRESSURE. THE SAME MALFUNCTION OCCURRED WITH A SECOND BALLOON OF THE SAME LOT. ULTIMATELY A THIRD BALLOON FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THE MALFUNCTIONS RESULTED IN A DELAY TO THE PROCEDURE AND THE PATIENT HAD TO BE KEPT UNDER ANESTHESIA 1 HOUR LONGER THAN PLANNED. REPORT 1 OF 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2082468 | SWIFT BALLOON DILATOR | BALLOON DILATOR | KNQ | HOBBS MEDICAL, INC. | BA-2 | O04-21-112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |