MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION GRAFTS ACCESSORIES TUNNELERS; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number 26012

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Information (3190)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

It was reported that after use the nurse disassembled the tunneler.It was noted that several pieces of metal had fallen off the shaft.

Manufacturer Narrative

Analysis: the complaint reported that multiple metal shavings or chips fell out of the av-1 tunneler after removing the tunneler tip.Multiple images of the metal chips were provided.None of the chips were returned and the tunneler rod was also not returned.Despite multiple good faith effort attempts no information was provided by the institution.Multiple questions were asked but none were answered.A review of the complaint log going back to 2013 shows that there has been no other complaints regarding metal chips reported.The original details provided indicate that the institution has had this tunneler since 2017.As the device in question was not returned atrium medical corporation cannot confirm that the metal chips had been produced by the machining process or if the tunneler tip had been crossed threaded or from a separate device all together.As the device was presumably used multiple times since the purchase in 2017 it is difficult to understand how metal chips would now be present after thoroughly cleaning and disinfecting the tunneler rod between uses.As part of the cleaning process the tunneler tip is removed so as the threaded area can be cleaned and any tissue removed from the area.A review of the component requirements as listed on the tunneler rod part drawing workmanship section states no burrs or sharp edges are permitted.Conclusion: based on the investigation atrium medical corporation can confirm that the metal chips came from the tunneler.H3 other text : product not returned.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Additional information: d4 and h4.Corrected data: e1.Analysis: the tunneler av-1 rod was returned as well as the metal chips or fragments.An inspection of the tunneler rod was conducted and there were no metal chips found inside the tunneler rod threads or taped hole.The threads were in perfect condition and there were no signs of damage or cross threading.The very bottom of the threaded orifice was viewed and it was not smooth or polished and there were no fragments loose.The metal chips were evaluated.There were multiple metal chips that appear to be from a milling process.Possibly from when the threaded hole was created by the vendor at the time (drt medical 618 greenmont blvd dayton ohio).A review was conducted of the sales records by getinge ssu sales representative that indicates that the likely lot number used in the procedure was 440220.This product lot was supplied by drt medical that is no longer providing tunneler rods to atrium medical corporation.To determine if the metal chips did indeed come from the tunneler rod itself an energy-dispersive x-ray spectroscopy (eds) test on the metal chips and tunneler rod was conducted.The analysis confirmed that the metal chips were of the same material as the av-1 tunneler rod confirming that the metal chips were likely from the tunneler rod.The analysis was undertaken by scanning the metal chips first followed by the av-1 tunneler rod as the material control sample as well as one of the tunneler rod tips.In all cases the materials were a match for stainless steel.To ensure there was not a systemic issue two finished good lots of tunneler rods were reviewed and inspected.Within the individual kits reviewed only one rod was produced by the current vendor (omni components).All other tunneler rods were produced by the prior supplier (drt medical).The tunneler rod kits included all components.The av-1 and av-2 tunneler rods as well as the pv-1 and pv-2 rods and supplied tunneler rod tips.All parts were reviewed for and metal chips specifically in the threaded orifice of each tunnel rod.No metal chips were observed.All the provided tips were smooth and there were no metal chips observed as well.In addition to the tunneler rods each of the individual tunneler rod tips from each kit were also inspected to ensure there were no metal chips on the threads of the tips and each tip was screwed into the tunneler rods to ensure there were still no metal chips present after screwing the tips into the individual tunneler rods.A review of the complaint log going back to 2013 shows that there has been no other complaints regarding metal chips reported.The original details provided indicate that the institution has purchased the tunneler kit on (b)(6) 2019.The information provided also states that the tunneler was used a second time on (b)(6) 2019.As part of the cleaning process the tunneler tip is removed so as the threaded area can be cleaned and any tissue removed from the area.During this step, it is likely any anomalies such as metal shavings would have been noticed.Conclusion: based on the investigation atrium medical corporation confirmed that the metal chips came from the tunneler rod based on the (eds) analysis that was conducted.Atrium medical corporation has never had a reported incident regarding metal chips before and the inspection of additional tunneler rods suggests that this is an isolated incident.The current supplier 100% inspects for metal chips in two separate manufacturing processes for the tunneler.

• Brand Name: GRAFTS ACCESSORIES TUNNELERS
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9162346
• MDR Text Key: 167206165
• Report Number: 3011175548-2019-01078
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00650862260120
• UDI-Public: 00650862260120
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2019

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: 12/18/2021
• Device Model Number: 26012
• Device Catalogue Number: 26012
• Device Lot Number: 440220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 10/28/2019; 06/24/2020
• Supplement Dates FDA Received: 10/30/2019; 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other