MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN PLUS KIT, 3 GUIDES, 5MM, 5PK; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number RSP0516MFS

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.[conclusion]: acclarent was informed on (b)(6) 2018, of an event which occurred on the same day during a balloon sinuplasty procedure involving a relieva spinplus kit, 3 guides, 5 mm kit (rsp0516mfs / 160427b-pc).The spinplus balloon catheter ruptured during the treatment of the left maxillary sinus.The balloon catheter was replaced with another balloon from lot number 170127a-pc and the case was successfully completed.There was no report of any patient injury or complication associated with the event; however, it was determined that the spinplus balloon catheter used for this procedure had expired on 04/27/2018.The products from lot# 160427b-pc was manufactured on 4/27/2016.During the investigation on when the expired product was purchased by the customer, the customer history showed that the customer purchased and received products from lot# 160427b-pc on 7/29/2016.Acclarent complaints handling reached out to the sales rep to request that the customer check the expiration dates on all acclarent products prior to use to ensure patient safety and product efficacy.Acclarent received the returned spin plus balloon catheter and the guide catheters (m-110, f-70, and s-0).Before decontamination, the returned device was visually inspected and was observed to be in normal condition.The device underwent decontamination for 2 hours before functional testing.The spinplus balloon catheter was connected to an inflation device and filled with water under pressure.The balloon catheter leaked during inflation; it was checked under the microscope and a burst was observed.The reported issue that the balloon burst was confirmed.Lot history record review was completed and confirmed that lot 160427b-pc met release specifications.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 (b)(6) 2018, of an event which occurred on the same day during a balloon sinuplasty procedure involving a relieva spinplus kit, 3 guides, 5 mm kit (rsp0516mfs / 160427b-pc).The spinplus balloon catheter ruptured during the treatment of the left maxillary sinus.The balloon catheter was replaced with another balloon from lot number 170127a-pc and the case was successfully completed.There was no report of any patient injury or complication associated with the event; however, it was determined that the spinplus balloon catheter used for this procedure had expired on 04/27/2018.

• Brand Name: RELIEVA SPIN PLUS KIT, 3 GUIDES, 5MM, 5PK
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine 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: 7581030
• MDR Text Key: 110728602
• Report Number: 3005172759-2018-00109
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031232839
• UDI-Public: 10705031232839
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2018
• Device Catalogue Number: RSP0516MFS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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