MAUDE Adverse Event Report: CORDIS US CORP ELITECROSS; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Catalog Number	MGC39140X
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the physician used two (2) elitecross 132cm extra support catheters on a patient along with an unknown hydrophilic wire to advance the elitecross proximal to a stented portion in the patient¿s superficial femoral artery (sfa).Upon advancement of the first elitecross over the wire, it was noticed that the catheter was unraveling.The physician then proceeded to pull a second elitecross catheter and advanced it over a hydrophilic wire distal to the stented portion in the patient¿s sfa and noticed that this elitecross was also unraveling, and a portion of the catheter had broken off and was left in the artery.The physician reported using a.035 non-cordis support catheter to recapture the piece of the elitecross that was broken off in the artery.The recovered piece is included in the complaint bag.The hospital is unable to confirm the lot number for either one of these elitecross catheters.Multiple attempts to gather additional information have been made and have been unsuccessful.The devices were returned for evaluation.
Additional Manufacturer Narrative
As reported, the physician used two (2) elitecross 132cm extra support catheters on a patient along with an unknown hydrophilic wire to advance the elitecross proximal to a stented portion in the patient¿s superficial femoral artery (sfa).Upon advancement of the first elitecross over the wire, it was noticed that the catheter was unraveling.The physician then proceeded to pull a second elitecross catheter and advanced it over a hydrophilic wire distal to the stented portion in the patient¿s sfa and noticed that this elitecross was also unraveling, and a portion of the catheter had broken off and was left in the artery.The physician reported using a.035 non-cordis support catheter to recapture the piece of the elitecross that was broken off in the artery.The recovered piece is included in the complaint bag.The hospital is unable to confirm the lot number for either one of these elitecross catheters.Two non-sterile ¿elitecross 132cm extra support catheter¿ devices were received for analysis.The first unit was analyzed under 2024-07272-1 and the second unit was analyzed under 2024-07272-2.2024-07272-1: during visual analysis, the unit presented with several kinked conditions located approximately 13.5, 46.5, and 86 cm from the distal tip.Additionally, a separated condition was observed on the brite tip.The separated material was not returned for analysis.Inner diameter (id) and outer diameter (od) measurements were taken in 3 places and were found within specification.Sem analysis was not performed because the damages associated with the separation are visible with the magnification obtained with a vision system.The brite tip was inspected with a vision system and the separated material presented with evidence of elongations and plastic deformation.Additionally, the braid wire presented with plastic deformation on the separated end.The reported customer event ¿catheter (body/shaft) "unraveled/stretched¿ was not confirmed on the first device (2024-07272-1) as this condition was not observed.However, the malfunction ¿brite tip/distal tip~ separated¿ was confirmed on both returned devices.A separated condition was noted on the brite tip of both catheters.The elongations and plastic deformation found on the material of the units are commonly associated with separations caused by material tensile/twist overload.Therefore, it is assumed the material was induced to a tensile/twist forces that exceeded the material yield strength prior to the separation.Excessive torquing of the catheters while the tip is entrapped in the vasculature may have contributed to the event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿if damage is detected in the catheter at any time, replace with an undamaged catheter.To prevent damage to the catheter during removal from the package, grasp the hub and withdraw the catheter.Torquing the catheter excessively may cause damage to the product and/or, specifically, result in possible separation along the catheter shaft.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.

• Brand Name: ELITECROSS
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 2301 centennial blvd; jeffersonville, indiana 47130 ; 7863138372
• MDR Report Key: 19697625
• Report Number: 1016427-2024-00019
• Device Sequence Number: 12692810
• Product Code: PDU
• UDI-Device Identifier: 20705032067536
• UDI-Public: 20705032067536
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: MGC39140X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN .035 QUICKCROSS.; UNKNOWN HYDROPHILIC WIRE.
• Patient Sex: Female