MAUDE Adverse Event Report: CORDIS CORPORATION ACCS CATH EXTEN 65CM 1200PSI; INTRODUCER, CATHETER

Model 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	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the ends of the catheter extension (ccs cath exten 65cm 1200psi) have sheared off at the point of where they screw into the catheter.There was no reported patient injury.The device is expected to be return for evaluation.The event involved two (2) devices both with the same lot number.The metal piece did not become detached and the devices were not used on a patient.
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.
Additional Manufacturer Narrative
As reported, the ends of the catheter extension (ccs cath exten 65cm 1200psi) have sheared off at the point of where they screw into the catheter.There was no reported patient injury.The event involved two (2) devices both with the same lot number.The metal piece did not become detached, and the devices were not used on a patient.The products were not returned for analysis however, it was reported both affected devices share the same lot number.A product history record (phr) review of lot 18062881 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿catheter extension-separated¿ could not be confirmed.Handling factors such as excessive pulling or twisting of the extension 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, ¿exposure to temperatures above 54°c (130°f) may damage the catheter extension.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.

• Brand Name: ACCS CATH EXTEN 65CM 1200PSI
• Common Device Name: INTRODUCER, CATHETER
• 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 Key: 14729617
• Report Number: 9616099-2022-05715
• Device Sequence Number: 20096208
• Product Code: DYB
• UDI-Device Identifier: 10705032064712
• UDI-Public: 10705032064712
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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: 09/30/2024
• Device Model Number: 502101D
• Device Catalogue Number: 502101D
• Device Lot Number: 18062881
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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
• Patient Sex: Unknown