MAUDE Adverse Event Report: CORDIS US. CORP CATHETER EXTENSION; INTRODUCER, CATHETER

Catalog Number	502101D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 65cm 1200psi catheter extension tubing was released while the metal part remained connected to a non-cordis catheter that was being used during this procedure and the tubing was separated.As a result, a new 65cm 1200psi catheter extension tubing was used, and the procedure was completed without any complications.No angiograms were taken with the extension tubing prior to the damage observed.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18173454 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 65cm 1200psi catheter extension tubing was released while the metal part remained connected to a non-cordis catheter that was being used during this procedure and the tubing was separated.As a result, a new 65cm 1200psi catheter extension tubing was used, and the procedure was completed without any complications.No angiograms were taken with the extension tubing prior to the damage observed.The device was discarded and will not be returned.
Additional Manufacturer Narrative
Complaint conclusion: a 65cm 1200psi catheter extension tubing was released while the metal part remained connected to a non-cordis catheter that was being used during this procedure and the tubing was separated.As a result, a new 65cm 1200psi catheter extension tubing was used, and the procedure was completed without any complications.No angiograms were taken with the extension tubing prior to the damage observed.The product was not returned for analysis.However, pictures were provided for review.One file with 3 pictures related to the reported event was attached by the customer.The picture #1 shows insert separated from the retainer (the catheter tubbing is not attached to the retainer).The picture #2 shows the inner label and the following information can be read: catalogue# 502101d, lot #18173454 and use by date# 2025-12-31.The picture #3 shows the retainer (attached to the tubing) held by the operator; the insert component is separated from the rest of the assembly.No other anomalies of the product were noted in the attached pictures.A product history record (phr) review of lot 18173454 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿retainer (extension tubing-only)-detached¿ and ¿catheter extension tubing - separated¿ were confirmed through analysis of the attached pictures.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the event.According to the safety information in the instructions for use, ¿to prevent damage, withdraw the catheter extension gently.Rapid removal or jerking may damage the extension.To minimize blood intrusion, keep the catheter extension filled with heparinized saline solution or contrast medium.¿ neither the phr review nor the product images analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time until the product is received to proceed with a complete analysis.

• Brand Name: CATHETER EXTENSION
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17407197
• Report Number: 9616099-2023-06560
• Device Sequence Number: 7121821
• Product Code: DYB
• UDI-Device Identifier: 10705032064712
• UDI-Public: (01)10705032064712(17)251231(10)18173454
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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 Catalogue Number: 502101D
• Device Lot Number: 18173454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/05/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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: PIGTAIL CATHETER BOSTON SCIENTIFIC
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White