MAUDE Adverse Event Report: ACCLARENT, INC. UNK_SPIN PLUS; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number UNK_SPIN PLUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Type  Death  

Event Description

The healthcare professional reported that ¿at some point in the last year, after a successfully completed balloon sinuplasty (bsp) procedure with a relieve spinplus device (unknown catalog / unknown lot), the patient female patient in her 20s suffered a heart attack and passed away.¿ it was reported that after the procedure completed, the patient complained about dizziness.The patient was laid down and instructed to relax.Then it was reported that the patient then suffered a heart attack and passed away.It was reported that all associated dates including the date of death are unknown.Limited additional was received on 18-mar-2022.The information indicated that the procedure was likely an in-office procedure.The procedure was to treat the sinuses and nasal airway obstruction (nao).General anesthesia was not used; a local cream or an injection was used.It was also reported that the acclarent product used during the bsp procedure were either spinplus or tract, or both.Since the patient underwent balloon sinuplasty procedure, it was assumed that the device used was a spinplus.It was reported that the device ¿worked fine and the procedure was completed as indicated with no device issues or complaints.It was not until after the procedure when the patient began to feel dizzy.¿ multiple attempts have been made to obtain additional information regarding this event directly from the treating physician.However, no additional information has been made available.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Date of death: the date of death is not known.Date of event: the date of the event is not known.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that ¿at some point in the last year, after a successfully completed balloon sinuplasty (bsp) procedure with a relieve spinplus device (unknown catalog / unknown lot), the patient female patient in her 20s suffered a heart attack and passed away.¿ it was reported that after the procedure completed, the patient complained about dizziness.The patient was laid down and instructed to relax.Then it was reported that the patient then suffered a heart attack and passed away.It was reported that all associated dates including the date of death are unknown.Limited additional was received on 18-mar-2022.The information indicated that the procedure was likely an in-office procedure.The procedure was to treat the sinuses and nasal airway obstruction (nao).General anesthesia was not used; a local cream or an injection was used.It was also reported that the acclarent product used during the bsp procedure were either spinplus or tract, or both.Since the patient underwent balloon sinuplasty procedure, it was assumed that the device used was a spinplus.It was reported that the device ¿worked fine and the procedure was completed as indicated with no device issues or complaints.It was not until after the procedure when the patient began to feel dizzy.¿ multiple attempts have been made to obtain additional information regarding this event directly from the treating physician.However, no additional information has been made available.Based on complaint information, the device is not available to be returned for analysis.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Based on the limited information contained in the complaint at the time the reporting determination was made, it is not possible to make clear determination of relation between accelerant devices, performed procedure and the patient¿s death.Acclarent takes the conservative approach to report this event.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.

• Brand Name: UNK_SPIN PLUS
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA; saret industrial park; building d3; po box 74-4002; alajuala 20101 ; CS 20101
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14088896
• MDR Text Key: 289167069
• Report Number: 3005172759-2022-00006
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPIN PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death
• Patient Sex: Female