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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION ACCS CATH EXTEN 100CM 1200PSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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CORDIS CORPORATION ACCS CATH EXTEN 100CM 1200PSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 502102D
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2022
Event Type  malfunction  
Event Description
As reported, before use of a 65cm 1200psi catheter extension in the patient, the manifold (circled iron connector) was put out of the catheter tip which is" like a broken catheter tip".It seemed that they were not connecting tightly.There was no reported patient injury.Additional information received indicated that a total of (9) devices were opened.It was further clarified that those devices were used continuously and the hospital wanted to change the stock.Based on the product evaluation findings, the catheter extension was found broken.
 
Manufacturer Narrative
As reported, before use of a 65cm 1200psi catheter extension in the patient, the manifold (circled iron connector) was put out of the catheter tip which is" like a broken catheter tip".It seemed that they were not connecting tightly.There was no reported patient injury.Additional information received indicated that a total of (9) devices were opened.(b)(4).During visual inspection, the unit was received with the insert cath ext broken and the retainer was found detached from the unit.Sem analysis on the broken portion of the catheter extension (insert) and presented evidence of fatigue striations and plastic deformation.A product history record (phr) review of lot 18079156 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The events reported by the customer ¿retainer (extension tubing only) ¿ detached¿ and ¿catheter extension ¿ separated¿ were confirmed for all nine of the returned devices.The catheter extension insert separated, which allowed the metal retainer to detach from the tubing.The fatigue striations and plastic deformations found on the material is commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the component was induced to a tensile force that exceeded the hub material yield strength prior to the separation.Handling factors such as rapidly jerking on the tubing may have contributed to the reported 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, ¿to prevent damage, withdraw the catheter extension gently.Rapid removal or jerking may damage the extension.¿ 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.
 
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Brand Name
ACCS CATH EXTEN 100CM 1200PSI
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014 2802
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014 2802
Manufacturer Contact
karla castro
14201 nw 60th avenue
miami lakes, FL 33014-2802
7863138372
MDR Report Key15131497
MDR Text Key300151541
Report Number9616099-2022-05864
Device Sequence Number1
Product Code DQO
UDI-Device Identifier10705032064729
UDI-Public10705032064729
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number502102D
Device Catalogue Number502102D
Device Lot Number18079156
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2022
Date Manufacturer Received07/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNK.
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