MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA FLEX SINUS GUIDE CATHETER, M-110; CANNULA, SINUS

Catalog Number GC110RF

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, weight, race, ethnicity, and medical history were not provided.[conclusion]: the healthcare professional reported that during the attempt to irrigate the maxillary sinus during the primary procedure on (b)(6) 2018, the blue tips at the end of the relieva flex sinus guide catheter, m-110 (gc110rf) came off on both catheters from the same lot (170112a-pc).Additional follow-up was performed on (b)(6) 2018, and the sales representative stated that the tip was still connected to the guide catheter.It was replaced, and the same issue occurred with the second catheter.The two guide catheters were returned for evaluation.One of the guide catheters was found to be missing the blue tip.The sales representative was contacted again for clarification, and she reported that when the guide catheter was removed from the patient the tip was still partially attached to the device; the blue tip fell off during the inspection of the guide catheter outside of the patient¿s anatomy.A third guide catheter was used to successfully complete the procedure.There was no report of any patient injury or adverse event.The relieva flex sinus guide catheter, m-110 was returned and received on 08/01/2018.The device was visually inspected prior to undergoing decontamination.The blue tip at the end of the guide catheter was observed to be missing.The reported issue was verified.The lot history record (lhr) was reviewed for lot the 170112a-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.With the information in the complaint and the additional information provided, the condition of the returned device was confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The cause of the initial partial tip separation could not be conclusively determined; the tip became completely separated when the removed device was being inspected.It is possible that the circumstance of the procedure and/or the device manipulation during the procedure may have contributed to the reported issue.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

The healthcare professional reported that during the attempt to irrigate the maxillary sinus during the primary procedure on (b)(6) 2018, the blue tips at the end of the relieva flex sinus guide catheter, m-110 (gc110rf) came off on both catheters from the same lot (170112a-pc).Additional follow-up was performed on (b)(6) 2018, and the sales representative stated that the tip was still connected to the guide catheter.It was replaced, and the same issue occurred with the second catheter.The two guide catheters were returned for evaluation.One of the guide catheters was found to be missing the blue tip.The sales representative was contacted again for clarification, and she reported that when the guide catheter was removed from the patient the tip was still partially attached to the device; the blue tip fell off during the inspection of the guide catheter outside of the patient¿s anatomy.A third guide catheter was used to successfully complete the procedure.There was no report of any patient injury or adverse event.

• Brand Name: RELIEVA FLEX SINUS GUIDE CATHETER, M-110
• 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: 7829635
• MDR Text Key: 118899708
• Report Number: 3005172759-2018-00113
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031063488
• UDI-Public: 10705031063488
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2019
• Device Catalogue Number: GC110RF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• 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
• Patient Age: 5 YR