MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA FLEX SINUS GUIDE CATHETER, F-70C; CANNULA, SINUS

Catalog Number GC070CRF

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).[conclusion]: acclarent was informed on 10/30/2018, of an event that occurred on (b)(6) 2018, involving the relieva flex sinus guide catheter f-70c (gc070crf / 180405a-pc).During the hybrid functional endoscopic sinus surgery (fess) procedure, the blue tip on the relieva flex sinus guide catheter broke off the guide catheter.It was reported that nothing was left inside the patient¿s anatomy; there was no harm or adverse event to the patient.Another guide catheter was opened as a replacement and the procedure was completed.The relieva flex sinus guide catheter f-70c and the separated blue tip were returned for evaluation.The investigation finding is documented below.The lot history record (lhr) was reviewed for lot 180405a-pc.No anomalies were found related to this complaint.In addition, the lhr review verifies that the device was manufactured in accordance with documented specification and procedures.Acclarent received the returned device on 11/19/2018.The package included the following: the relieva flex sinus guide catheter f-70c.The separated blue tip of the guide catheter.Upon receiving the returned device before decontamination, the returned device underwent visual inspected.The relieva flex sinus guide catheter was noted to have a missing blue tip.The separated blue tip included in the package was covered in dry blood.The device underwent decontamination for two hours in a 10% bleach solution.After decontamination, the guide catheter was inspected under the microscope and the reported issue that the blue tip became separated from the guide catheter as reported in the complaint was confirmed.With the information provided in the complaint and the returned device for investigation, the issue reported that the blue tip broke off the guide catheter was confirmed from visual inspection and microscopic inspection of the returned device.Based on the lot history record (lhr) review, there is no indication that the event is related to the device manufacturing process.The exact cause of the failure could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

Acclarent was informed on 10/30/2018, of an event that occurred on (b)(6) 2018, involving the relieva flex sinus guide catheter f-70c (gc070crf / 180405a-pc).During the hybrid functional endoscopic sinus surgery (fess) procedure, the blue tip on the relieva flex sinus guide catheter broke off the guide catheter.It was reported that nothing was left inside the patient¿s anatomy; there was no harm or adverse event to the patient.Another guide catheter was opened as a replacement and the procedure was completed.The guide catheter and the separated blue tip will be returned for evaluation.

• Brand Name: RELIEVA FLEX SINUS GUIDE CATHETER, F-70C
• Type of Device: CANNULA, SINUS
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8096703
• MDR Text Key: 129307203
• Report Number: 3005172759-2018-00115
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031063426
• UDI-Public: 10705031063426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2020
• Device Catalogue Number: GC070CRF
• Device Lot Number: 180405A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1