FDA Adverse Event
Malfunction
Summary report: N
N/A
MDR report key: 20663902
·
Received November 12, 2024
Report
- Report Number
- 3011610434-2024-00011
- Event Type
- Malfunction
- Date Received
- November 12, 2024
- Date of Event
- October 16, 2024
- Report Date
- November 12, 2024
- Manufacturer
- INNOVATIVE HEALTH, LLC.
- Product Code
- PNE
- UDI-DI
- 10841898120275
- PMA / PMN Number
- K170311
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
INNOVATIVE HEALTH LLC BECAME AWARE ON 16-OCT-2024 OF A REPROCESSED AGILIS NXT STEERABLE INTRODUCER REPORTED TO HAVE A LEAKY STOPCOCK. NO INJURIES OR OTHER CLINICAL SIGNS/SYMPTOMS WERE REPORTED. INNOVATIVE HEALTH MADE FOLLOW-UP ATTEMPTS TO OBTAIN THE COMPLAINT DEVICE ON 24-OCT-2024 AND 5-NOV-2024 WITH NO RESPONSE. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED AND NO ANOMALIES WERE NOTED. BASED ON THE INFORMATION AVAILABLE AND NOT BEING ABLE TO COMPLETE FURTHER INVESTIGATION ON THE COMPLAINT DEVICE, INNOVATIVE HEALTH CANNOT CONFIRM THERE WERE PERFORMANCE ISSUES WITH THE REPROCESSED AGILIS NXT STEERABLE INTRODUCER.
Description of Event or Problem · 0
ON (B)(6) 2024, IT WAS REPORTED THAT THERE WAS A DEVICE THAT HAD A LEAKY STOPCOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1539897 | N/A | STEERABLE INTRODUCER | PNE | INNOVATIVE HEALTH, LLC. | 408310 | 10841898120275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |