MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SUCTION, 0 - 1PK; TRUDI NAV SUCTION, 0

Catalog Number TDNS000Z

Device Problem Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, weight, race, ethnicity, and medical history were not provided.The device lot number is not available / not reported.The device does not have an expiration date as it is a non-sterile re-usable device.The name, phone and email address of the initial reporter are not available / reported.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2019-00122.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 procedure targeting the sphenoid sinus, the trudi suction device (tdns000z / s/n: (b)(4) / lot# unk) was not in its accurate location; it was off by more than 2mm.There was no issue noted during the set up and registration of the suction tool.The device was initially accurate and then later appeared to be inaccurate.This issue was not noticed in previous uses of the device.When the loss of accuracy was observed, the icon on the trudi system was green.The physician was able to connect to a new suction device.The procedure was completed without any patient injury.It was reported that the suction device has been reprocessed less than 5 times.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a primary balloon sinuplasty procedure targeting the sphenoid sinus, the trudi suction device (tdns000z / s/n: 1901080049 / lot# unk) was not in its accurate location; it was off by more than 2mm.There was no issue noted during the set up and registration of the suction tool.The device was initially accurate and then later appeared to be inaccurate.This issue was not noticed in previous uses of the device.When the loss of accuracy was observed, the icon on the trudi system was green.The physician was able to connect to a new suction device.The procedure was completed without any patient injury.It was reported that the suction device has been reprocessed less than 5 times.The product was returned for evaluation.The investigational finding is documented below.Investigation summary: the trudi suction device was received.Before undergoing decontamination, visual inspection was performed.There was no appearance of damage observed.The returned device underwent decontamination with a 10% bleach solution for two hours.After decontamination, the following electrical tests were performed and completed using the lab multimeter (id#: us2172.Calibrated on 02-15-2019 / due on 02-29-2020): 1) sensor connectivity: 0l mo (specification: 188 o ± 25 o).2) shield connectivity to stainless steel body: 1.4o (specification is < 10 o).3) the eeprom connectivity: 439.5 ko (specification is > 50 ko and < 10mo).4) isolation between sensor and shield: 0l mo (specification is > 1 mo).5) isolation between sensor and eeprom input/output (i/o): 0l mo (specification is > 1 mo).6) isolation between sensor and eeprom ground (gnd): 0l mo (specification is > 1 mo).7) isolation between shield and eeprom input/output (i/o): 0l mo (specification is > 1 mo).8) isolation between shield and eeprom ground (gnd): 0l mo (specification is > 1 mo).Note: 0l mo indicates the reading exceeds the maximum indicated value of the multimeter.Upon completion of the electrical test, it was identified that the sensor connectivity test resulted in an out of specification result reading of 0l mo (specification: 188 o ± 25 o).The reported issue that the trudi suction device was not in its accurate location was confirmed based on the evaluation and functional analysis performed on the returned device.It was identified that the sensor connectivity was out of specification (specification: 188 o ± 25 o); the multimeter reading was 0l mo.The device lot number was not available.The device history record (dhr) review could not be performed without the lot number.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.Updated sections: g.4, g.7, h.2, h.3, h.6, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2019-00121 and 3005172759-2019-00122.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: TRUDI SUCTION, 0 - 1PK
• Type of Device: TRUDI NAV SUCTION, 0
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8843781
• MDR Text Key: 158688192
• Report Number: 3005172759-2019-00121
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10705031245877
• UDI-Public: 10705031245877
• Combination Product (y/n): N
• PMA/PMN Number: K180948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TDNS000Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: 6X16MM RELIEVA SPINPLUS NAV; TRUDI CABLE - 5PK