MAUDE Adverse Event Report: ACCLARENT RELIEVA FLEX SINUS GUIDE CATHETER

Model Number F-70C

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/05/2014

Event Type  malfunction  

Event Description

Acclarent was informed of an event that was said to have occurred during a procedure in which relieva flex sinus guide catheters were said to have been used.The user facility reported that during a balloon sinuplasty of the left maxillary sinus recess, the balloon leaked and could not be inflated, after having treated five other sinuses successfully.Analysis of the returned product was completed on 12/05/2014 and revealed that the distal blue tip of the sinus guide catheter detached from the nylon shaft and was stuck inside the shaft.On 12/18/2014, it was confirmed that the physician had identified the tip detachment at the end of the procedure, after dilating the left frontal sinus and removing the balloon catheter.The physician checked and confirmed that no debris remained in the patient's sinus recess.No patient injury was reported as a result of the tip detaching and being stuck in the nylon shaft.

Manufacturer Narrative

Review of manufacturing records associated with the subject devices did not detect any manufacturing anomalies.Acclarent will continue to monitor this phenomenon for trending purposes.

• Brand Name: RELIEVA FLEX SINUS GUIDE CATHETER
• Type of Device: SINUS GUIDE CATHETER
• Manufacturer (Section D): ACCLARENT; menlo park CA
• Manufacturer Contact: izabel nielson, sr. manager ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4381567
• MDR Text Key: 20732010
• Report Number: 3005172759-2014-00033
• Device Sequence Number: 1
• Product Code: KAM
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K043445
• 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: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2015
• Device Model Number: F-70C
• Device Catalogue Number: GC070CRF
• Device Lot Number: 131113D-CM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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 Age: 67 YR