MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV RAILWAY ACCESS KIT, 6F, VBT, SS WIRE; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email address is: (b)(6).This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
A physician removed a sheathless catheter from a 6f railway sheathless access system and was wiping the railway down when it snapped completely in half.The component that sheared off was not retained in the patient.There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
Please note update to the udi# in section d4.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
The device was returned and section d9 was updated accordingly.The completed engineering report will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
A physician removed a sheathless catheter from a 6f railway sheathless access system and was wiping it down when it snapped completely in half.The component that sheared off was not retained in the patient.There was no reported patient injury.The device will be returned for evaluation.A non-sterile ¿railway access kit, 6f, vbt, ss wire¿ was received for evaluation.Only the vessel dilator 0.035 and one label were returned for analysis.A separated condition was noted at the fused area approximately 118.5 cm from the proximal tip.The separated segment with a length of approximately 17.5 cm was not returned for analysis.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Sem results presented evidence of elongations on the body/shaft material of the unit.A product history record (phr) review of lot 17999875 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint ¿vessel dilator ~ separated¿ was confirmed.The returned unit presented with a separation.The exact cause of this damage could not be conclusively determined during the analysis however, the elongations found on the body/shaft material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft was induced to a tensile force that exceeded the body/shaft material yield strength prior to the separation.Procedural/handling factors such as vessel characteristics may have contributed to this issue.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, ¿avoid the use of the railway¿ sheathless access system in vasculature with extreme tortuosity, calcified plaque or thrombus.Caution: if extreme tortuosity or strong resistance is encountered during advancement or withdrawal of the catheter, discontinue movement, and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: RAILWAY ACCESS KIT, 6F, VBT, SS WIRE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer (Section G): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12647137
• Report Number: 9616099-2021-04941
• Device Sequence Number: 1240443
• Product Code: DYB
• UDI-Device Identifier: 10705032076906
• UDI-Public: 10705032076906
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: RW6VBTB
• Device Lot Number: 17999875
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 12/01/2021; 01/31/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/04/2021; 12/22/2021; 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2021
• 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 SHEATHLESS CATHETER; UNKNOWN SHEATHLESS CATHETER
• Patient Sex: Unknown