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

Catalog Number RSP0616MFS

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

Lot number 161028a-pc a review of the lot history record for the subject device did not note any anomalies.The investigation is in progress; once the investigation is completed, a supplemental report will be sent.(b)(4).

Event Description

Acclarent was informed on (b)(4) 2017, that the packaging pouch containing the relieva spinplus, 3 guides, 6mm, 5pk (lot number# 161028a-pc) that was to be used for a primary procedure on the same day has a hole on the tyvek side.The issue was discovered before the start of the procedure by the nurse.The spinplus device was not used during the procedure; the device was not used on the patient.The device was replaced.There was no report of patient injury or complication as the product was not used.The hole in the packaging compromised the sterility of the product.As a result, this event is mdr reportable.

Manufacturer Narrative

It was reported, that the packaging pouch containing the relieva spinplus has a hole on the tyvek side.Acclarent received the package on 9/5/2016.The returned package included the following: a.Spin plus.B.Guide catheters (m-110, f-70 and s-0).Upon receiving the package, the product was visually inspected and it was found: the puncture site is raised when viewing the damage from the inside of the pouch.The puncture site is depressed when viewing the damage from the outside of the pouch.There is no shape edge observed on tray.Based on the above three observations, it has been determined that the puncture showed signs that the damage was the result of force being applied to the pouch from the outside.During investigation, it was found in packaging area, special tools with blunt edges are used.It was attempted to reproduce the defect; however, the defect could not be replicated.There are adequate controls in place that would have detected the damaged pouch.This issue was unlikely to have happened during the manufacturing process at acclarent since all devices are manufactured and packaging in accordance with documented specifications and procedures and passed all required release criteria.In addition, on line inspections are in place to prevent this type of defect prior leaving the facility.The failure mode of this complaint cannot be confirmed.

• Brand Name: RELIEVA SPINPLUS
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 6884770
• MDR Text Key: 89464129
• Report Number: 3005172759-2017-00052
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: K143541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

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: No Information
• Device Catalogue Number: RSP0616MFS
• Device Lot Number: 161028A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 08/28/2017
• Supplement Dates FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1