MAUDE Adverse Event Report: ACCLARENT RELIEVA SPIN BALLOON SINUPLASTY SYSTEM; SINUS BALLOON CATHETER

Catalog Number RS0616M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/12/2014

Event Type  Injury  

Event Description

Acclarent was informed of an event that occurred during an in-office procedure where an acclarent spin balloon sinuplasty device was used.On the second attempt to dilate the maxillary sinus pus began pouring out of the sinus which reportedly obstructed the physician's view.The physician retracted the balloon slightly and was able to perform a second and third dilation with more pus coming out of the sinus.After the third dilation, bleeding occured, and the physician replaced the pledget to control the bleeding prior to working on the frontal sinus.Physician asked the patient to stay in the office longer to control the bleeding.Physician later reported that the patient was still bleeding and was unable to determine the source due to the blood and pus coming out of the maxillary sinus.Patient was not on anti-coagulants but is being treated for hypertension.Physician later packed the patient's nose and sent her home and scheduled a return visit the following day.Patient follow up showed the patient is doing well with no further sequelae reported.

Manufacturer Narrative

The device referenced in this report was discarded and was not available for evaluation.The physician reported having no difficulties in using the acclarent device during or after the procedure.The cause of the reported bleeding could not be conclusively determined.This is acclarent's initial reported case of hemorrhage during a procedure in which a spin balloon sinuplasty system was used.A supplemental report will be submitted if additional info is received, and acclarent will continue to monitor this phenomenon for trending purposes.

• Brand Name: RELIEVA SPIN BALLOON SINUPLASTY SYSTEM
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT; menlo park CA
• Manufacturer Contact: izabel nielson,sr mgr ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4112594
• MDR Text Key: 4926254
• Report Number: 3005172759-2014-00024
• 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
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RS0616M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: THERAPY DATE:; UNK PLEDGET AND ICE PACK
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR