MAUDE Adverse Event Report: ACCLARENT INC RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM; GUIDE WIRE

Catalog Number RS0616FZ

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2015

Event Type  malfunction  

Event Description

Guidewire would not engage.No harm to patient.Manufacturer response for guide wire, relieva balloon sinuplasty system (per site reporter): do not know talked to or.

• Brand Name: RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ACCLARENT INC; 33 technology dr.; irvine CA 92618
• MDR Report Key: 5350163
• MDR Text Key: 35236470
• Report Number: 5350163
• 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: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/12/2018
• Device Catalogue Number: RS0616FZ
• Device Lot Number: 150612A-CM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR