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

Model Number RSP0616MFS

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during a primary hybrid functional endoscopic sinus surgery (fess) procedure, during the treatment of the first sinus in the procedure, the frontal guide tip was placed on the tip of the 6mm x 16mm relieva spinplus balloon catheter (rsp0616mfs / 200803a-pc) and when the balloon was advanced during treatment of the frontal sinus, a piece of the balloon sheath broke off in the patient¿s nose.The patient¿s anatomy was unremarkable; there was no issue related to the patient¿s anatomy that could have contributed to the reported event; there was no issue encountered when the device was introduced into the patient¿s anatomy.Suction was used to remove the piece of broken sheath from the patient¿s anatomy.It took 2 minutes to open another 6mm x 16mm relieva spinplus balloon catheter (rsp0616mfs), the procedure was then resumed and was successfully completed.It was reported that a 0-degree scope was used and the guide tip was determined not to be the source of the reported issue.There was no report of any patient adverse event or complication associated with the reported issue.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the complaint device was received; inspection was performed and the product was found in good condition.The frontal guide catheter was returned with the device.No damage was observed on the frontal guide; no separated fragment was observed.The balloon shaft was inspected and it was found without any damage.Functional testing was performed.The balloon catheter was inflated completely indicating that there was no separated fragment as reported.A review of manufacturing documentation associated with this lot (200803a-pc) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Since the reported malfunction of the balloon catheter separated inside of the patient required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is considered serious and reportable.The balloon catheter fragmenting a piece during the procedure inside of the patient requiring the remnant piece to be removed is a mdr reportable malfunction and since the event required a the medical intervention of suctioning out the separated piece, this event meets mdr reporting criteria as a ¿serious injury.¿ the complaint reported that during the primary hybrid fess procedure, the frontal guide tip was placed on the tip of the 6mm x 16mm relieva spinplus balloon catheter and when the balloon was advanced during treatment of the frontal sinus, a piece of the balloon sheath broke off in the patient¿s nose.Suction was used to remove the piece of broken sheath from the patient¿s anatomy.The reported issue could not be confirmed based on the inspection and functional evaluation performed on the returned device.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Although there was no product defect identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the functional analysis performed in the product analysis lab.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.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 hybrid functional endoscopic sinus surgery (fess) procedure, during the treatment of the first sinus in the procedure, the frontal guide tip was placed on the tip of the 6mm x 16mm relieva spinplus balloon catheter (rsp0616mfs / 200803a-pc) and when the balloon was advanced during treatment of the frontal sinus, a piece of the balloon sheath broke off in the patient¿s nose.The patient¿s anatomy was unremarkable; there was no issue related to the patient¿s anatomy that could have contributed to the reported event; there was no issue encountered when the device was introduced into the patient¿s anatomy.Suction was used to remove the piece of broken sheath from the patient¿s anatomy.It took 2 minutes to open another 6mm x 16mm relieva spinplus balloon catheter (rsp0616mfs), the procedure was then resumed and was successfully completed.It was reported that a 0-degree scope was used and the guide tip was determined not to be the source of the reported issue.There was no report of any patient adverse event or complication associated with the reported issue.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to make a correction to section e1: initial reporter postal code.The initial reporter zip code is (b)(6) and it was mistakenly added in the postal code field in section e1.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.The initial reporter zip code is (b)(6) and it was mistakenly added in the postal code field.E1: zip code: (b)(6).

• 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
• MDR Report Key: 11325439
• MDR Text Key: 235005009
• Report Number: 3005172759-2021-00002
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031232389
• UDI-Public: 10705031232389
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/03/2022
• Device Model Number: RSP0616MFS
• Device Catalogue Number: RSP0616MFS
• Device Lot Number: 200803A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 16X40MM RELIEVA TRACT BALLOON DILATION SYSTEM; ACCLARENT BALLOON INFLATION DEVICE; ACCLARENT SE INFLATION DEVICE
• Patient Outcome(s): Required Intervention