NASASTENT
Report
- Report Number
- 3006524618-2021-00536
- Event Type
- Injury
- Date Received
- May 1, 2021
- Report Date
- May 24, 2021
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- LYA
- UDI-DI
- 00817470004946
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MU
- Reporter Occupation
- PHYSICIAN
Narratives
INTERNAL COMPLAINT REFERENCE (B)(4).
H10 H3,H6: THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION OF THE FOIL POUCH FOUND NO DEFECT TO THE DEVICE PRIMARY PACKING. THE VISUAL INSPECTION OF THE DEVICE INSIDE THE POUCH ALSO DID NOT FIND ANY DEFECT. A FUNCTIONAL EVALUATION FOUND THE NASASTENT DEVICE STAYED IN CONTACT WITH THE WALLS OF THE MODEL THROUGH THE INCUBATION TIME CONFIRMING AT LEAST 72 HOURS RESIDENCE TIME. THE DEVICE ALSO ABSORBED FLUID FROM THE NASAL CHAMBER AND TURNED INTO GEL OVER THE SAME TIME-PERIOD. THE NASASTENT DEVICE THAT HAS TURNED INTO A GEL CAN BE REMOVED FROM THE NASAL MODEL BY SUCTION AND IRRIGATION. THE NASASTENT RR1000 TESTED MEETS ALL THE REQUIREMENTS OF MINIMUM RESIDENCE TIME, ABSORBS FLUIDS TURNS INTO HYDROCOLLOIDAL GEL, AND CAN BE REMOVED BY SUCTION AND IRRIGATION. A CLINICAL/MEDICAL EVALUATION DETERMINED THAT BASED ON THE LIMITED INFORMATION PROVIDED WE ARE CURRENTLY UNABLE TO RULE OUT A PROCEDURAL VARIANCE AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT, WHICH DOES NOT REPRESENT A DEVICE MALFUNCTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT.
IT WAS REPORTED THAT, AFTER A FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE PATIENT COMPLAINED 1/2 WEEKS AFTER THE CASE OF SEVERE PAIN AND HEADACHE ON A POST-OP VISIT. THE "RAPID RHINO, DISSOLVABLE NASAL DRESSING" DID NOT DISSOLVE AFTER FOLLOWING HYDRATION GUIDELINES AND TRIMMING METHOD. THE HYDRATION WAS DONE WITH 2ML OF DEXAMETHASONE DURING DRESSING INSERTION AFTER NASAL SURGERY. ADDITIONALLY, THE PATIENT WAS INSTRUCTED TO USE NASAL SPRAY POST-OPERATIVELY. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AS THE PATIENT HAD MORE ADHESION AND CRUSTING OF THE DRESSING TO REMOVE, WHICH BLOCKED THE NORMAL OUTFLOW. THE PATIENT RECOVERED FROM PAIN AND HEADACHE AFTER REMOVAL BY SUCTION-ASPIRATION OF THE NASASTENT WITHOUT ANY FURTHER TREATMENT.
INTERNAL COMPLAINT REFERENCE (B)(4).
IT WAS REPORTED THAT, AFTER A NASAL SURGERY, THE PATIENT WAS COMPLAINING OF A SEVERE PAIN AND HEADACHE. THE "RAPID RHINO, DISSOLVABLE NASAL DRESSING" WAS NOT DISSOLVING AFTER FOLLOWING HYDRATION GUIDELINES AND TRIMMING METHOD. THE PATIENT HAD TO BE READMITTED TO THE HOSPITAL AND NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT STATUS OF THE PATIENT ITS UNKNOWN. BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654808 | NASASTENT | SPLINT, INTRANASAL SEPTAL | LYA | ARTHROCARE CORP. | RR1000 | 2039143 | 00817470004946 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O |