MAUDE Adverse Event Report: ACCLARENT RELIEVA FLEX SINUS GUIDE CATHETER

Model Number F-70C

Device Problems Shelf Life Exceeded (1567); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 11/07/2014

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 maxillary sinus recess, the distal blue end of the sinus guide catheter detached from the distal end of the catheter.At the time of the procedure, the physician identified the detachment and visualized the detached tip with an endoscope.The detached tip was recovered by the physician using an unknown pair of surgical forceps.A second flex sinus guide catheter was used and it too reportedly detached and was recovered using forceps.No patient injury was reported in either of these 2 instances of tip separation, however the physician elected to abandon the balloon sinuplasty procedure after the second occurrence and the patient was treated with functional endoscopic sinus surgery (fess).

Manufacturer Narrative

The subject devices are being returned for evaluation.Review of manufacturing records associated with the subject devices did not detect any manufacturing anomalies.A supplemental report will be submitted with the results of the evaluation following receipt of the devices.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. mgr ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4345442
• MDR Text Key: 5176242
• Report Number: 3005172759-2014-00032
• Device Sequence Number: 1
• Product Code: KAM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• 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: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: F-70C
• Device Catalogue Number: GC070CRFZ
• Device Lot Number: 120814D-CM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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: UNK SURGICAL FORCEPS