MAUDE Adverse Event Report: ACCLARENT RELIEVA FLEX SINUS GUIDE CATHETER

Model Number F-70C

Device Problem Material Fragmentation (1261)

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

Event Date 02/23/2015

Event Type  malfunction  

Event Description

Accelerant was informed of an event occurred during a procedure in which a relieva flex sinus guide catheter was used.During a hybrid procedure to dilate the frontal sinus, the user attempted to advice the sinus balloon, and the balloon catheter body reportedly "gave way" and kinked at the top part.The surgeon reportedly noted that the guide catheter tip looked "out of shape" and there were "small pieces of foreign objects in the endoscopic view of the pt's anatomy." the foreign material was removed using suction.Saline was observed to leak from a crack in the balloon catheter shaft.The sinus guide catheter and balloon catheter were replaced, and the procedure was completed.There was no report of pt harm associated with the event, and the pt is reportedly doing fine.Following the procedure, the user indicated that the pt had suspected tortuous anatomy, and that the spaces were very tight in the area of the procedure.

Manufacturer Narrative

The subject device is pending 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: 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: 4647297
• MDR Text Key: 15347838
• Report Number: 3005172759-2015-00005
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2015
• Device Model Number: F-70C
• Device Catalogue Number: GC070CRF
• Device Lot Number: 130521D-CM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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: (LOT 130604D-CM); RELIEVA SOLO PRO SINUS BALLOON CATHETER 3.5X12 MM,; RELIEVA ULTIRRA SINUS BALLOON CATHETER 5X16 MM,; (LOT 131002F-CM); RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER,; UNK MODEL OF ENDOSCOPE; (LOT 120220D-CM); RELIEVA ULTIRRA SINUS BALLOON CATHETER 5X16 MM,; (LOT 130604D-CM); RELIEVA LUMA SENTRY SINUS ILLUMINATION SYS,; ACCLARENT BALLOON INFLATION DEVICE (LOT 96427020); (LOT 131203F-CM)
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR