FDA Adverse Event
Injury
Summary report: N
PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHE
MDR report key: 3703802
·
Received March 5, 2014
Report
- Report Number
- 3004672932-2014-00002
- Event Type
- Injury
- Date Received
- March 5, 2014
- Date of Event
- November 14, 2013
- Report Date
- March 5, 2014
- Manufacturer
- ONSET MEDICAL CORPORATION
- Product Code
- EZN
- PMA / PMN Number
- K043254
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
AS REPORTED: DR. (B)(6) USED THE PATHWAY ON AN ALREADY STENTED PT. THE PATHWAY WAS INFLATED TO 25ATM FOR EXACTLY 45 SEC WHEN BALLOON MALFUNCTIONED. UNDER VISION, DR. NOTED A SMALL RUPTURE IN THE URETER. HE ABORTED THE CASE AND STENTED THE PT UNTIL RECOVERY OF THE URETER. ALL PROCEDURES WERE FOLLOWED ACCORDING TO THE PRODUCT INFLATION INSTRUCTIONS AND IT'S UNCLEAR AS TO WHY THE PRODUCT MALFUNCTIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134114 | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHE | INTRODUCER | EZN | ONSET MEDICAL CORPORATION | 255101 | W034587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |