FDA Adverse Event
Malfunction
Summary report: N
SENDERO MAX DELIVERY CATHETER
MDR report key: 24031708
·
Received January 12, 2026
Report
- Report Number
- 3016444913-2026-00001
- Event Type
- Malfunction
- Date Received
- January 12, 2026
- Date of Event
- December 11, 2025
- Report Date
- January 9, 2026
- Manufacturer
- OKAMI MEDICAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K242644
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
NO SERIOUS INJURY WAS ASSOCIATED WITH THE REPORTED INCIDENT, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT, AND NO ADDITIONAL ADVERSE EVENTS WERE REPORTED FOR THE PATIENT. A DHR REVIEW REVEALED NO DEVIATIONS FROM THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT.
Description of Event or Problem · 0
A REPRESENTATIVE REPORTED THAT A MINOR VESSEL DISSECTION OCCURRED DURING A PAVM PROCEDURE INVOLVING THE USE OF A SENDERO MAX DELIVERY CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97119 | SENDERO MAX DELIVERY CATHETER | CATHETER, PERCUTANEOUS | DQY | OKAMI MEDICAL INC. | SENDERO-MAX55-110MP | 25K0004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |