MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN SINUPLASTY GUIDE; INSTRUMENT, ENT MANUAL SURGICAL

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

Lot history record review was completed and confirmed that lot 141112e-cm met release specifications.The acclarent failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

Acclarent was informed on 04/15/2016, of an event on (b)(6) 2016, in which the sterile package of an acclarent relieva spin sinuplasty guide, m-110c (lot#: 141112e-cm) was open.The sterility of the package was compromised.There was no report of patient consequence as the guide was not used due to the compromised sterility.

Manufacturer Narrative

It was reported that the sterile package of an acclarent relieva® spin sinuplasty guide, m-110c (lot#: 141112e-cm) was open.Acclarent received the package on 5/2/2016.The returned package contained the relieva® spin sinuplasty guide, m-110c.Upon receiving the package, the product was visually inspected and the following were observed: the bottom of the pouch remains sealed.The seal boundary is fairly uniform along the edges.Traces of fiber uniformly left on the plastic film on the opened portion of the pouch.The creases on the left and right of seal surface showed that forces appeared to have been applied in the opposite directions in order to break the seal.This issue was unlikely to have happened during the manufacturing process at acclarent since all devices are manufactured and packaged in accordance with documented specifications procedures and passed all required release criteria.In addition, in line inspections are in place to prevent this type of defect prior to the products leaving the facility.The failure mode of this complaint (pouch was not sealed) cannot be confirmed since acclarent manufacturing processes can be ruled out as a potential cause of the alleged non-conformance.

• Brand Name: RELIEVA SPIN SINUPLASTY GUIDE
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497899383
• MDR Report Key: 5651827
• MDR Text Key: 45100809
• Report Number: 3005172759-2016-00010
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111875
• 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,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2017
• Device Model Number: N/A
• Device Catalogue Number: RSM110C
• Device Lot Number: 141112E-CM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1