INTERA
Report
- Report Number
- 3015537318-2025-00099
- Event Type
- Injury
- Date Received
- October 24, 2025
- Date of Event
- September 25, 2025
- Report Date
- November 20, 2025
- Manufacturer
- INTERA ONCOLOGY, INC
- Product Code
- LKK
- UDI-DI
- 00850014110093
- PMA / PMN Number
- P890055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
RATIONALE FOR CORRECTION: UPDATING SECTION D1 AND D10. AS PREVIOUSLY MENTIONED, THE PHYSICIAN STATED THAT THE PUMP WAS FUNCTIONING PROPERLY PRIOR TO IMPLANTATION. THEREFORE, THE CAUSE OF THIS REPORT IS TRACED TO PATIENT'S ANATOMY.
A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. AS PREVIOUSLY MENTIONED, THE PHYSICIAN STATED THAT THE PUMP WAS FUNCTIONING PROPERLY PRIOR TO IMPLANTATION. THEREFORE, THE CAUSE OF THIS REPORT IS TRACED TO PATIENT'S ANATOMY.
INTERA ONCOLOGY RECEIVED A REPORT FROM A PHYSICIAN THAT THE IMPLANT WAS ABORTED DUE TO PATIENT'S ANATOMY BEING INSUFFICIENT FOR TAPERED CATHETER. THE PHYSICIAN REPORTED THAT THE PUMP WAS FUNCTIONING PROPERLY PRIOR TO IMPLANTATION. DURING COMMUNICATION WITH THE PHYSICIAN, HE MENTIONED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTIONS. HE CONFIRMED THE PUMP WAS IN THE PUMP POCKET AND REMOVED AFTER DETERMINING THAT THE PATIENT'S ANATOMY IS INSUFFICIENT TO THE TAPERED CATHETER.
INTERA ONCOLOGY RECEIVED A REPORT FROM A PHYSICIAN THAT THE IMPLANT WAS ABORTED DUE TO PATIENT'S ANATOMY BEING INSUFFICIENT FOR TAPERED CATHETER. THE PHYSICIAN REPORTED THAT THE PUMP WAS FUNCTIONING PROPERLY PRIOR TO IMPLANTATION. DURING COMMUNICATION WITH THE PHYSICIAN, HE MENTIONED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTIONS. HE CONFIRMED THE PUMP WAS IN THE PUMP POCKET AND REMOVED AFTER DETERMINING THAT THE PATIENT'S ANATOMY IS INSUFFICIENT TO THE TAPERED CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1966608 | INTERA | TAPERED VASCULAR CATHETER | LKK | INTERA ONCOLOGY, INC | IP-37957 | 19703 | 00850014110093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Other |