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

Catalog Number	451514H0
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	09/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, when using a 5f 100cm 135-degree vertebral (vert) tempo diagnostic catheter to perform a 3cc angiogram of the aortic arch, the tip end of the device was found dislodged.The angiogram was performed with a syringe and the distal tip had dislodged within the aortic arch.The dislodged tip was removed with an unknown snaring device in conjunction with a surgical incision made at the femoral artery.The procedure was concluded after the removal of the distal tip.The device was stored and prepped per the instructions for use (ifu).There were no difficulties inserting the device into the patient prior to performing the angiogram.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, when using a 5f 100cm 135-degree vertebral (vert) tempo diagnostic catheter to perform a 3cc angiogram of the aortic arch, the tip end of the device was found dislodged.The angiogram was performed with a syringe and the distal tip had dislodged within the aortic arch.The dislodged tip was removed with an unknown snaring device in conjunction with a surgical incision made at the femoral artery.The procedure was concluded after the removal of the distal tip.The device was stored and prepped per the instructions for use (ifu).There were no difficulties inserting the device into the patient prior to performing the angiogram.A video was attached to the event by the customer, showing that a possible failure in the fusion between the tip and the catheter body caused a separation between both components.One non-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, a separation was noted between the tip and the body of the unit.No other damages or anomalies were observed on the returned device.Due to the separated components found during visual review; amplified images were taken.The distal end of the body is noted to be reduced before the fusing process with the tip.The tip was inspected internally and marks from the braided body were noted.Due to the conditions found, an sem (scanning electron microscope) analysis was performed.Sem analysis revealed elongations and material transfer from the body to the tip¿s inner surface, suggesting incomplete bonding likely caused by misalignment during manufacturing.This defect highlights the importance of proper heat, pressure, and alignment to ensure structural integrity, as deviations can result in weak bonding, like the one observed in the original complaint (see sem report for further information).A dsc (differential scanning calorimetry) was performed to the plastics involved on the issue.Based on the dsc results, it is suggested that the material was exposed to some type of external stimulus such as heat, since the reaction enthalpies and the two melting points appeared in samples 1 and 2 compared to the control samples.In addition, the improvement of the properties in sample 3 suggests a change in the part.Only dsc was performed as the amount of sample required for each analysis was not sufficient to perform tga and dsc analysis, however the analysis performed gives enough information to address the objective of this special service request (see the dsc report for further information).The complaint reported as ¿brite tip/distal tip - separated¿ has been confirmed, as the product evaluation revealed a separation between the catheter body and tip.Visual inspection identified no other damages, but sem analysis uncovered elongations and material transfer at the interface, indicating incomplete bonding.The sem findings suggest that misalignment or other factors during the fusion process may have compromised the structural integrity of the joint.Additionally, dsc analysis revealed changes in the polymer properties, including altered enthalpies and multiple melting points, which imply exposure to external heat stimuli.These thermal changes further support the conclusion that improper fusion between the components occurred during manufacturing.Given the results of the analysis, the complaint will be escalated to ensure further investigation.A risk assessment has been initiated to escalate this issue.The product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a corrective/preventive action will be taken at this time.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 20438389
• Report Number: 9616099-2024-00341
• Device Sequence Number: 15520535
• Product Code: DQO
• UDI-Device Identifier: 10705032008464
• UDI-Public: (01)10705032008464(17)270430(10)18319158
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 451514H0
• Device Lot Number: 18319158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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 SNARING DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 60 KG