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

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/14/2014

Event Type  Injury  

Event Description

Acclarent was informed of an event that occurred following a procedure where the subject device was used.The device was said to have worked without difficulty during the procedure, and the surgeon successfully dilated an unknown number of sinuses.Sometime after the procedure, the patient was said to have experienced extensive nasal bleeding.The patient presented to the emergency room of a nearby hospital where he reportedly "coded".The patient was revived by the attending physician and the bleeding was stopped.The patient had a follow up visit with the surgeon who performed the procedure a few days after the reported event, and the patient was described as doing well with no further sequelae.

Manufacturer Narrative

Acclarent followed up with the surgeon who performed the procedure and was informed that prior to the procedure, the patient took ibuprofen, tylenol and an unknown third pain reliever against the physician's instructions and contrary the facility's patient checklist.The device referenced in this report was discarded by the user facility and was not available for evaluation.The cause of the reported bleeding could not be conclusively determined, and the use of anti-inflammatory or other medication cannot be ruled out as a contributing factor the post-surgical bleeding.Acclarent multiple times, via telephone and in writing to contact the physician who performed the procedure to obtain additional information on the cause of the bleeding with no response.If additional information is received regarding this report, a supplemental report will be filed.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, INC.; menlo park CA
• Manufacturer Contact: izabel nelson, sr. mgr. ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4135421
• MDR Text Key: 4948984
• Report Number: 3005172759-2014-00026
• 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: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2014
• Initial Date FDA Received: 09/26/2014
• 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
• Patient Outcome(s): Required Intervention