MAUDE Adverse Event Report: ACCLARENT RELIEVA FLEX SINUS GUIDE CATHETER; FLEX GUIDE CATHETER

Catalog Number GC110RF

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/17/2014

Event Type  malfunction  

Event Description

It was reported that after dilating the right maxillary sinus the physician was about to insert the device into the left maxillary sinus when it was observed that the blue tip of the sinus guide catheter was missing.The physician examined the right maxillary sinus.The user reported that the tip was located inside a blood clot that had already been removed from the pt earlier in the same procedure.The guide was replaced and the procedure was successfully completed.

Manufacturer Narrative

The device referenced is being returned for eval.Review of mfg records associated with the subject device did not detect any anomalies.A supplemental report will be submitted with the results of the eval following receipt of the device.Acclarent will continue to monitor this phenomenon for trending purposes.

• Brand Name: RELIEVA FLEX SINUS GUIDE CATHETER
• Type of Device: FLEX GUIDE CATHETER
• Manufacturer (Section D): ACCLARENT; menlo park CA
• Manufacturer Contact: izabel nielson, sr. mgr, post ma ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4066676
• MDR Text Key: 4734288
• Report Number: 3005172759-2014-00020
• Device Sequence Number: 1
• Product Code: KAM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2015
• Device Catalogue Number: GC110RF
• Device Lot Number: 130403E-CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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
• Treatment: ACCLARENT FLEX M-90 SINUS GUIDE CATHETER