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

Catalog Number	451514H0
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, upon receipt of a shipment of 5f 100 cm tempo vertebral contrast catheters, scratches were found on the inside of one of the catheters.Additionally, black spots were found on the body of four (4) other catheters, which were suspected to be contaminated.The condition was noted after the product had been received and stored in the lab, prior to use.There was no reported patient injury.There were no damages to the packaging or device.The devices were stored as per the instructions for use (ifu) in the sterile processing department (spd) warehouse and product cabinets.None of the sterile pouches received were open or compromised.The inner package seal was not opened in anticipation of use and then reshelved.Pictures were provided for review.The pictures were reviewed and apparent scratches are observed on the central section of the hub.Additionally black particles are observed on the body of the unit.The position of the anomalies observed, either inside or outside the packaging could not be determined on the pictures provided.The devices were returned for evaluation.
Additional Manufacturer Narrative
The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, upon receipt of a shipment of 5f 100 cm tempo vertebral contrast catheters, scratches were found on the inside of one of the catheters.Additionally, black spots were found on the body of four (4) other catheters, which were suspected to be contaminated.The condition was noted after the product had been received and stored in the lab, prior to use.There was no reported patient injury.There were no damages to the packaging or device.The devices were stored as per the instructions for use (ifu) in the sterile processing department (spd) warehouse and product cabinets.None of the sterile pouches received were open or compromised.The inner package seal was not opened in anticipation of use and then reshelved.A sterile unit of catheter cath tempo 5f ver 135° 100cm was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.During the visual inspection, kinked/bent conditions were observed on the unit, however those kinks coincide with the folds made in the unit for it to be placed in the plastic bag.No other damages or anomalies were observed on the returned device to the naked eye.For the kinked/bent conditions found on the unit, no dimensional analysis was performed since the damages were caused by the folding of the unit to be shipped.The unit was inspected using the vision system.The entire length and components were inspected using the system.A black spot was found on the body of the unit, this black spot looked incrusted on the material of the body and, no alteration was felt to the touch on the surface, neither a protrusion nor a dent in the material.Dimensional analysis was performed to verify the size of the black spots found on the microscopical analysis.Dimensional analysis results were found within specification, since the spot on the catheter can be accepted if it is less than or equal to 0.050¿.In this case the spot found is around 0.020¿.Functional analysis was performed.Flushing test was performed on the unit returned.No anomalies such as leakage, obstruction, nor difficulties were noted in any of the components of the unit.The event reported by the customer as ¿catheter (body/shaft) - foreign material¿ was confirmed since a black spot was found embedded in the body of the unit.Dimensional analysis was performed on this spot.Although the black spot on the catheter body is manufacturing-related, it falls within acceptable quality standards.The black spot's size is well below the maximum allowable threshold, without affecting the function or safety of the device.Although this device falls within specification, any deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance should be replaced and the affected device should be sent back for evaluation.Given the adherence to quality specifications and the lack of functional impact, no corrective actions will be taken.

• 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 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 20292947
• Report Number: 9616099-2024-00320
• Device Sequence Number: 18174445
• Product Code: DQO
• UDI-Device Identifier: 10705032008464
• UDI-Public: (01)10705032008464(17)270531(10)18336676
• 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
• Report Date (Section B): 11/08/2024

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 Catalogue Number: 451514H0
• Device Lot Number: 18336676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2024
• 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: UNKNOWN.
• Patient Sex: Unknown