MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number RSP0616MFS

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.[conclusion]: the healthcare professional reported that during a primary balloon sinuplasty (bsp) procedure on (b)(6) 2019, targeting the frontal, maxillary, and sphenoid sinuses, the frontal guide catheter tip on the 6mm 3 guides relieva spinplus kit (rsp0616mfs / 190627a-pc) cracked when it was inserted into the patient¿s nasal cavity.It was reported that the tip cracked but did not become separated from the rest of the guide catheter.No pieces fell into or were left in the patient¿s anatomy.The physician verified using the endoscope (stryker) and confirmed that there was no particle left in the patient.The device was replaced with another 6mm 3 guides relieva spinplus kit (rsp0616mfs), and the physician completed the procedure.There was no report of any patient adverse event or complication.The product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: acclarent received the returned package on 1/14/2020.The package was comprised of the following: relieva spin plus, guide catheters (s-0, f-70, and m-110).Before decontamination, the product and its components were visually inspected.The s-0 and m-100 guide catheters were observed without any damage.The f-70, the plastic distal portion frontal guide catheter was observed broken with a crack/fracture near the steel shaft; the break was not complete as it was still connected to the rest of the guide catheter.The returned device underwent a two-hour decontamination in a 10% bleach solution after the visual inspection.The lot history record (lhr) was reviewed for this lot (190627a-pc).There were no anomalies found related to this complaint.In addition, the lhr review verified that the device was manufactured in accordance with documented specification and procedures.The issue documented in the complaint that the frontal guide catheter tip was cracked when it was inserted into the patient¿s nasal cavity was confirmed with the visual inspection performed on the returned device.Based on the device lot history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the reported issue 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.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.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

The healthcare professional reported that during a primary balloon sinuplasty (bsp) procedure on (b)(6) 2019, targeting the frontal, maxillary, and sphenoid sinuses, the frontal guide catheter tip on the 6mm 3 guides relieva spinplus kit (rsp0616mfs / 190627a-pc) cracked when it was inserted into the patient¿s nasal cavity.It was reported that the tip cracked but did not become separated from the rest of the guide catheter.No pieces fell into or were left in the patient¿s anatomy.The physician verified using the endoscope (stryker) and confirmed that there was no particle left in the patient.The device was replaced with another 6mm 3 guides relieva spinplus kit (rsp0616mfs), and the physician completed the procedure.There was no report of any patient adverse event or complication.

• Brand Name: RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK
• 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9589485
• MDR Text Key: 175850044
• Report Number: 3005172759-2019-00125
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031232389
• UDI-Public: 10705031232389
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2020
• Device Catalogue Number: RSP0616MFS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2019
• 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