MAUDE Adverse Event Report: ARTHROCARE CORP. SINU FOAM; SPLINT, INTRANASAL SEPTAL

Catalog Number RR 650

Device Problems Device Ingredient or Reagent Problem (2910); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 02/17/2017

Event Type  Injury  

Event Description

It was reported that sinufoam stayed in the maxillary sinuses for 4-6 months causing an infection that required revision surgery.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the product in question was not returned for evaluation.Thus, the customer¿s complaint could not be verified, nor could a root cause be determined with confidence.It is possible the product was not sufficiently hydrated with lactated ringer solution or water, which could delay the timeline for product dissolution.It is also possible the patient did not irrigate properly after implantation.The instructions for use (ifu) provided with the device contains warnings and precautionary measures related to proper use of the device including but not limited to: - have the patient irrigate with light isotonic saline solution (0.65%) until first office visit (do not irrigate with hypertonic saline solution or bulb style syringe until after first office visit).- any residual dressing that has not dissolved or left the surgical site through normal outflow passages may be easily aspirated at the discretion of the surgeon.There were no indications during manufacturing record review that would suggest the product did not meet product specifications upon release into distribution.

Event Description

It was reported that, after a sinus procedure, sinufoam stayed in the maxillary sinuses for 5 months causing a severe infection that required bilateral sinus revision surgery.All the material was washed out.Patient was prescribed sinus rinses with surfactant to remove biofilm effect.

• Brand Name: SINU FOAM
• Type of Device: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 w. william cannon; austin, TX 78735 ; 5123913905
• MDR Report Key: 6594138
• MDR Text Key: 76060465
• Report Number: 3006524618-2017-00133
• Device Sequence Number: 1
• Product Code: LYA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: RR 650
• Device Lot Number: 4100203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female