MAUDE Adverse Event Report: CONMED CORPORATION TUBE SET 24K TRUE INTRA-ARTICULAR PRESSURE SENSING; ARTHROSCOPE

Catalog Number 24KTIPS

Device Problems Excess Flow or Over-Infusion (1311); Increase in Pressure (1491); Material Rupture (1546); Pressure Problem (3012)

Patient Problems No Consequences Or Impact To Patient (2199); Joint Swelling (2356)

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

The used 24ktips tube set is not expected to be returned for evaluation, as it was discarded at the user facility after the surgery.As of this filing the investigation remains in process, a supplemental and final report will be filed upon the completion of the complaint investigation.Device was discarded at user facility.

Event Description

On (b)(6) 2017, conmed (b)(4) received an email from the surgeon, who alleged that at least 4 times over the last 3-4 week he has had a situation where during use of the 24ktips in a rotator cuff repair procedure, the 24k pump started to pump at "crazy pressure with the shoulder swelling up tremendously in a short period of time".The report further stated that upon inspection it was found that the "bladder inside the tubing" had ruptured, leading to the pump not being able to sense the actual pressure and a "dangerously high continuous inflow of fluid".As reported, the procedure performed on (b)(6) 2017 was completed as planned with the use of another 24ktips from the same lot.In addition, follow-up with the surgeon confirmed that "excess fluid was absorbed naturally" and there was no serious injury occurred or any long term adverse effect anticipated to the patient.However, attempts to verify if there were 3 other separate incidents and if so, the dates of the individual incident for the other 3 alleged cases with the surgeon and the theater manager have failed to confirm such incidents.To date, no additional patient/event information, no incident dates from the other mentioned cases could be obtained from the surgeon and/or facility.Should additional information become available, the complaints will be generated and processed accordingly.This report is filed on the basis of potential for patient injury with recurrence.

Manufacturer Narrative

As reported, the involved device was disposed of by the user facility and is therefore not available for further evaluation.However, the user facility provided a photograph of the involved device.Visual inspection of the photo found the "bladder" inside the tubing had ruptured and this confirmed the reported finding from the surgeon.In this instance, without the actual device, an evaluation could not be performed and the root cause of the reported "bladder ruptured" could not be determined.Evaluation of a previous complaint from the same user facility revealed that the balloon within the 24ktips can collapse if connected to the patient before connecting to the pump (such that pressure regulation will not work).The user facility has since been made aware of this requirement.An in-service was also conducted after the reported incident with the surgeon and his team, where the correct use of the 24ktips tubing was reviewed.This lot #201612084 was manufactured on 09-dec-2016.A review of the device history record for this lot found no noted of discrepancies during the manufacturing process that could have caused or contributed to reported issue.Of the lot containing 288 units, there have been no other similar complaints received for this item and lot number combination.In addition, a 2-year review of product history for this device shows other than this complaint there have been no other similar complaints received.During this same 2-year time frame, approximately (b)(4).To date, there have been no serious injuries or death related to the reported issue or the use of this device.This reported issue will continue to be monitored via the complaint system to ensure product safety.This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable.This tubing set is intended for use, in conjunction with the conmed linvatec 24k system, to improve pressure measurement accuracy during arthroscopic procedures.To reduce the risk of patient injury, the instructions for use (ifu) provides the user with the following precautions and warnings: - avoid abrupt changes in joint position, which may result in high intra-articular pressure spikes and/or extravasation.- do not crimp, kink, puncture or roll over the tips tubing set with carts or other equipment.Erroneous readings may result, possibly causing injury and/or extravasation to the patient.- connect the tips tubing set to the console first, then to the cannula.If connected in reverse order, the tips system may not measure joint pressure accurately and may result in compromised performance.- periodically examine the distal location of the inflow cannula or sheath to ensure that the cannula or sheath is within the joint capsule.Extravasation may occur as a result of improper cannula or sheath placement or excessive intra-articular joint pressure.- for tips to operate properly, pressure sensing should occur in the joint space closest to the working space.Failure to do so may result in increased risk of extravasation.- extravasation may occur if the pressure sensing system does not function properly.Always perform a patency test prior to each procedure.- do not squeeze the tips balloon while the pump is operating.Unexpected acceleration of the pump may occur.- frequently examine and palpate the patient's joint to check for extravasation and proper distention.Device was discarded at user facility.

• Brand Name: TUBE SET 24K TRUE INTRA-ARTICULAR PRESSURE SENSING
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, cp, 1136 ; MX 1136
• Manufacturer Contact: n. kim grady ; 525 french road; utica, NY 13502-5994 ; 7273995479
• MDR Report Key: 6615008
• MDR Text Key: 76950974
• Report Number: 3007305485-2017-00133
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2021
• Device Catalogue Number: 24KTIPS
• Device Lot Number: 201612084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 07/06/2017
• Supplement Dates FDA Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1