MAUDE Adverse Event Report: CORDIS US CORP. TEMPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	451415V0
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	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the white tip (radiopaque tip) detached from the 4f ber ii tempo 0.38¿ 65 cm angiographic catheter and it was embedded in the patient's artery wall plaque and seen on x-ray.The segment was not retrieved; it was embedded in the patient's plaque.The artery was stented by the physician.The patient is in stable condition.Two (2) images were received for review.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.Additional event details were requested; however, not provided.The device was discarded.
Additional Manufacturer Narrative
As reported, the white tip (radiopaque tip) detached from the 4f ber ii tempo 0.38¿ 65 cm angiographic catheter, was embedded in the patient's artery wall plaque and seen on x-ray.The segment was not retrieved; it was embedded in the patient's plaque.The artery was stented by the physician.The patient is in stable condition.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.Two pictures related to the reported failure were submitted for review.Picture #1 shows the inner label of the product, and the following information can be read: lot# 18128856, catalogue# 451-415v0 and use by date 2025-06-30.Picture #2 shows the distal section of the catheter inside a pouch.The brite tip is missing, and no blood residue could be observed.The failure reported by the customer as ¿brit tip/distal tip-separated¿ was confirmed.The brite tip could not be observed as part of the picture evaluation.However, the device was not returned for evaluation therefore, the exact cause of the reported event cannot be determined.Excessive manipulation of the catheter while the tip was embedded in the patient¿s artery wall plaque may have led to the separation.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.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ based on the information, there is no indication this event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18023258
• Report Number: 9616099-2023-06619
• Device Sequence Number: 7758689
• Product Code: DQO
• UDI-Device Identifier: 10705032007870
• UDI-Public: (01)10705032007870(17)250630(10)18128856
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973401
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024

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: 06/30/2025
• Device Catalogue Number: 451415V0
• Device Lot Number: 18128856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 12/01/2023; 08/14/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/12/2023; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT DISCLOSED.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown