MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F VER 135 DEGREE 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451414H0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18097607 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, the anterior segment of the 4f 0.038in x 100cm tempo vertebral coated nylon diagnostic contrast catheter was found to be "dehiscent" when being withdrawn after being used for contrast and placement.The contrast catheter was replaced and the "contrast was good".There were no reports of patient injury.However, the hospital reported it as an adverse event to the china nmpa directly.The patient had been diagnosed with left iliac vein occlusion and left lower extremity vein thrombosis.The procedure that the patient had to undergo was inferior vena cava filter placement, left iliac vein balloon dilation, and left iliac vein stent placement as prescribed by the doctor.The device was not returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h6, and h10 complaint conclusion: as reported, the anterior segment of the 4f 0.038in x 100cm tempo vertebral coated nylon diagnostic contrast catheter was found to be "dehiscent" when being withdrawn after being used for contrast and placement.The contrast catheter was replaced and the "contrast was good".There were no reports of patient injury.However, the hospital reported it as an adverse event to the china nmpa directly.The patient had been diagnosed with left iliac vein occlusion and left lower extremity vein thrombosis.The procedure that the patient had to undergo was inferior vena cava filter placement, left iliac vein balloon dilation, and left iliac vein stent placement as prescribed by the doctor.The device was not returned for evaluation.A product history record (phr) review of lot 18097607 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft)-cracked - in-patient¿ could not be confirmed without the return of the device for evaluation.Procedural and/or handling factors such as device damage upon removal from the packaging or loading a wire.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, ¿treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ 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: CATH TEMPO 4F VER 135 DEGREE 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16222999
• Report Number: 9616099-2023-06232
• Device Sequence Number: 5273157
• Product Code: DQO
• UDI-Device Identifier: 10705032007856
• UDI-Public: 10705032007856
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973401
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 451414H0
• Device Catalogue Number: 451414H0
• Device Lot Number: 18097607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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