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

Model Number RSP0616MFS

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The device lot number is not available / not reported.The expiration date of the device is not known.The initial reporter name and email address are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.The healthcare professional reported that during an in-office balloon sinuplasty (bsp) procedure, the tip of the 6mm relieva spin plus balloon catheter (rsp0616mfs / lot# unknown) broke off during the treatment of the frontal sinus.It was reported that the top of the balloon was bent, and the tip separated and broke off as the balloon was being inflated using the acclarent se inflation device (seid / lot# unknown).The physician removed the separated tip from the patient¿s anatomy.It was confirmed that the balloon was appropriately folded prior to its insertion into the patient¿s frontal sinus cavity.The procedure was completed using a new spin plus balloon catheter and a new acclarent se inflation device.There was no report of any patient adverse event or complication.The balloon catheter device was returned for evaluation.The investigational finding is documented below.Investigation summary: acclarent received the returned relieva spinplus balloon catheter.Before decontamination, the device underwent visual inspection.It was observed that the balloon component had separated from the shaft; the balloon component and the tip of the balloon were not returned.The complaint documented that the tip of the 6mm relieva spin plus balloon catheter broke off during the procedure.The reported issue was confirmed based on the visual inspection performed.The device lot number was not available.The device history record (dhr) review could not be performed without the lot number.The exact cause of the balloon separation from the shaft and the tip of the balloon catheter breaking off during the procedure could not be conclusively determined.It is possible that circumstances of the procedure and/or device manipulation while accessing the patient¿s frontal sinus may have contributed to the tip of the balloon catheter becoming bent and ultimately breaking off from the device.The lot number of the device is not known; therefore, review of the device history record was not performed.Devices undergo inspection during the final assembly / packaging process; thus, it is not likely that the 6mm relieva spin plus balloon catheter left the manufacturing facility with the tip of the balloon catheter in a bent state that would have resulted in it breaking off or of the balloon component missing from the shaft of the device.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 an in-office balloon sinuplasty (bsp) procedure, the tip of the 6mm relieva spin plus balloon catheter (rsp0616mfs / lot# unknown) broke off during the treatment of the frontal sinus.It was reported that the top of the balloon was bent, and the tip separated and broke off as the balloon was being inflated using the acclarent se inflation device (seid / lot# unknown).The physician removed the separated tip from the patient¿s anatomy.It was confirmed that the balloon was appropriately folded prior to its insertion into the patient¿s frontal sinus cavity.The procedure was completed using a new spin plus balloon catheter and a new acclarent se inflation device.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.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9880076
• MDR Text Key: 187741543
• Report Number: 3005172759-2020-00001
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSP0616MFS
• Device Catalogue Number: RSP0616MFS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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