MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPINPLUS; ENT MANUAL SURGICAL INSTRUMENT

Model Number RSP0616MFS

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

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

Event Date 05/25/2017

Event Type  malfunction  

Event Description

During a frontal sinus surgical procedure, the balloon catheter failed.The sinus balloon did not hold the nacl and leaked/burst.There was no harm to the patient.Investigation summary: the balloon catheter was sent to the manufacturer where it was inspected.The manufacturer tested the balloon by connecting it to an inflation device filled with water under pressure, and water was leaked during inflation.The catheter was checked under microscope and a balloon burst was discovered on catheter.This facility's complaint was verified.The manufacturer reviewed the lot history records and found no anomalies related to this complaint.

• Brand Name: RELIEVA SPINPLUS
• Type of Device: ENT MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology dr.; irvine CA 92618
• MDR Report Key: 6720772
• MDR Text Key: 80295239
• Report Number: 6720772
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/11/2018
• Device Model Number: RSP0616MFS
• Device Catalogue Number: RSP0616MFS
• Device Lot Number: 161111A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR