MAUDE Adverse Event Report: ARTHROCARE CORP. STAMMBERGER SINUS DRESSING; SPLINT, INTRANASAL SEPTAL

Catalog Number EDRR 650

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that dissolvable foam inserted intra-nasally did not dissolve and patient required further surgery to clean sinuses.This condition did not cause any damage to the patient, device did not require to be replaced or removed.As per reporter, there is no further information regarding lot number or patient information.

Manufacturer Narrative

The product was not returned for evaluation and had been used for treatment.A relationship, if any, between the product and the reported event could not be determined since the product was not returned for evaluation.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.

• Brand Name: STAMMBERGER SINUS DRESSING
• 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: jim gonzales ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 7237643
• MDR Text Key: 98984506
• Report Number: 3006524618-2018-00061
• Device Sequence Number: 1
• Product Code: LYA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2018
• Device Catalogue Number: EDRR 650
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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