FDA Adverse Event
Malfunction
Summary report: N
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
MDR report key: 6956797
·
Received October 17, 2017
Report
- Report Number
- 2135342-2017-00004
- Event Type
- Malfunction
- Date Received
- October 17, 2017
- Date of Event
- September 13, 2017
- Report Date
- September 18, 2017
- Manufacturer
- HERAEUS MEDICAL COMPONENTS, LLC
- Product Code
- OCY
- PMA / PMN Number
- K150225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF MANUFACTURING AND STERILIZATION RECORDS SHOWED THE DEVICE MET SPECIFICATIONS.
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED, THEREFORE NO DEVICE EVALUATION COULD BE PERFORMED. MINIMAL INFORMATION WAS PROVIDED REGARDING THE PROCEDURE. REVIEW OF MANUFACTURING AND STERILIZATION RECORDS COULD NOT BE PERFORMED BECAUSE THE PRODUCT LOT NUMBER WAS NOT PROVIDED. HERAEUS IS UNABLE TO COMMENT ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE THE DISTAL TIP OF THE WIRE HAD BROKE IN THE PATIENT BUT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE OUTCOME AND PATIENT CONDITION ARE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735882 | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE | ENDOSCOPIC GUIDEWIRE | OCY | HERAEUS MEDICAL COMPONENTS, LLC | 5201 | MO45106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |