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

Catalog Number RS0616F

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

Patient Problems Stroke/CVA (1770); Cerebrospinal Fluid Leakage (1772)

Event Date 09/16/2014

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was discarded by the user facility and was not available for evaluation. Review of manufacturing records associated with the subject device did not detect any anomalies. The physician reported having no difficulties in using the acclarent device during or after the procedure. The extent to which the subject device caused or contributed to the reported event cannot be determined. If additional info 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 that occurred during a procedure in which a reliev a spin balloon sinuplasty system and traditional rigid instruments, including an unidentified freer-elevator device were used. The procedure was said to involve bilateral frontal, maxillary and sphenoid sinus dilation. A preoperative ct scan had been performed which reportedly identified no skull base defect. Following dilation of both frontal and maxillary sinuses, and one sphenoid sinus, the physician began dilating the second sphenoid sinus. During dilation, the physician reported having observed clear fluid leaking from the patient's nose, and identified a csf leak from the area of the cribriform plate. The patient was transferred to a local hospital via ambulance where a subsequent ct scan identified a skull base defect. The patient was taken to the operating room where the attending surgeon reportedly identified the cerebrospinal fluid leak in the patient's sphenoid sinus, and the leak was repaired under general anesthesia. Sometime thereafter, the patient reportedly experienced a "cerebrovascular accident", which the surgeon reported most likely related to spasm of regional blood vessels. Acclarent followed up with the user facility and was informed tha the patient was released from the hospital and is doing well.

• Brand Name: RELIEVA SPIN BALLOON SINUPLASTY SYSTEM
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT, INC.; menlo park CA
• Manufacturer Contact: izabel nielson, sr mgr ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4184198
• MDR Text Key: 12474592
• Report Number: 3005172759-2014-00029
• 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

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/06/2017
• Device Catalogue Number: RS0616F
• Device Lot Number: 140606A-CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/16/2014 Patient Sequence Number: 1

Treatment

MODEL#: UNK, THERAPY DATE:; FREER-ELEVATOR AND OTHER RIGID INSTRUMENTATION,