MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN SINUPLASTY SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/09/2015

Event Type  Injury  

Manufacturer Narrative

Acclarent products were used during the procedure, along with rigid instruments of an unknown type, and a frontal and sphenoid sinus seeker.Acclarent products were reported to have functioned as expected.The physician noted that he believed that the nosebleed was a result of the patient taking blood thinners.No acclarent devices are available to be returned for evaluation as they were discarded by the user facility.If additional information is received regarding this report, a supplemental report will be filed.Acclarent will continue to monitor this phenomenon for trending purposes.

Event Description

Acclarent was informed of an event in which an adult female patient was said to have developed a nosebleed (epistaxix) following a balloon sinuplasty procedure of all sinuses performed in the physician's office.An acclarent relieva spin 6x16 sinuplasty system was said to have been used along with rigid instruments (unknown type) and a frontal and sphenoid sinus seeker during the procedure, which was performed on (b)(6) 2015.The surgeon reported that the balloon sinuplasty portion of the surgery went as planned with no complications, and the patient was sent home.After an unknown amount of time following the procedure, the patient's family member contacted the physician due to the patient developing a nosebleed.The physician met the patient at the hospital and treated the nosebleed (specific treatment is not known), and the nosebleed was resolved.The patient is said to have recovered with no other issues reported.

• Brand Name: RELIEVA SPIN SINUPLASTY SYSTEM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 1525-b o'brien dr.; menlo park CA
• Manufacturer Contact: joaquin kurz ; 1525-b o¿brien dr; menlo park, CA 94025 ; 9497899383
• MDR Report Key: 5210897
• MDR Text Key: 30737939
• Report Number: 3005172759-2015-00016
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RS0516MFS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: RIGID INSTRUMENTS, FRONTAL & SPHENOID SEEKER
• Patient Outcome(s): Hospitalization; Required Intervention