MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 5F VER 135 DEGREE 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451514H0

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

As reported, the tip of a tempo 5f vertebral 135 degree 100cm catheter was used normally, and the tip "fractured".There was no reported patient injury.The device will not be returned for evaluation.The hospital reported it as an adverse event to the china nmpa directly.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18062368 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.

Manufacturer Narrative

As reported, the tip of a tempo 5f vertebral 135-degree 100cm catheter was used normally, and the tip "fractured".There was no reported patient injury.The product was not returned for analysis.A product history record (phr) review of lot 18062368 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 ¿brite tip/distal tip- cracked¿ could not be confirmed.Procedural/handling factors (significant manipulation and excessive torquing) and/or vessel characteristics (calcification, stenosis, and tortuosity) 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, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ 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.

Manufacturer Narrative

As reported, the tip of a tempo 5f vertebral 135-degree 100cm catheter was used normally, and the tip "fractured".There was no reported patient injury.The device was not being used for treatment of a chronic total occlusion.The device was not used in the patient.There was no additional intervention required due to anomaly.Additional intervention was not required to prevent patient injury.There was no resistance met while withdrawing the device.There were no anomalies noted when the device was taken out of the package.There were no anomalies noted during or after the device was prepped.The device was inspected prior to opening the package.The procedure was diagnostic.The target site was the internal carotid artery.The femoral artery was the access site.The device stored and prepped per the instructions for use (ifu).The user was trained to the device.There was no difficulty experienced in prepping the device.A contralateral approach was not used."the tip of the product was broken, and the position of the fall off is within the second branch of the internal iliac." one non-sterile unit of catheter cath tempo 5f ver 135 degree 100cm was received for analysis.During visual inspection, the brite tip/distal tip was found separated.The distal tip was not returned for evaluation.A scanning electron microscope (sem) and an energy dispersive x-ray (eds) analysis was performed on the separated area.Sem results presented evidence of elongations and possible material transfer.Eds results showed a difference between the elements on the samples, which confirmed material transfer.The tip contains a radiopaque element1 (technetium).The body of the catheter does not contain this radiopaque element, which suggests the material found on the distal end of the separation, is part of the distal tip.This may indicate a fusion was performed between both materials.A product history record (phr) review of lot 18062368 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿brite tip/distal tip ¿ cracked¿ could not be confirmed because the brite tip/distal tip was not returned for analysis.The event ¿brite tip/distal tip ¿ separated - in-patient¿ was confirmed.The distal tip was separated from the body/shaft of the unit.The elongations and material transfer found on the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed the distal tip was induced to a tensile force that exceeded the material yield strength prior to the separation.The exact cause of the reported events cannot be conclusively determined.Removing the catheter from its packaging by the distal tip or withdrawing the catheter from the patient against resistance are possible contributing factors.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, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ 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.

Event Description

As reported, the tip of a tempo 5f vertebral 135 degree 100cm catheter was used normally, and the tip "fractured".There was no reported patient injury.The device was not being used for treatment of a chronic total occlusion.The device was not used in the patient.There was no additional intervention required due to anomaly.Additional intervention was not required to prevent patient injury.There was no resistance met while withdrawing the device.There were no anomalies noted when the device was taken out of the package.There were no anomalies noted during or after the device was prepped.The device was inspected prior to opening the package.The procedure was diagnostic.The target site was the internal carotid artery.The femoral artery was the access site.The device stored and prepped per the instructions for use (ifu).The user was trained to the device.There was no difficulty experienced in prepping the device.A contralateral approach was not used."the tip of the product was broken, and the position of the fall off is within the second branch of the internal iliac." other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will not be returned for evaluation.The hospital reported it as an adverse event to the china nmpa directly.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, and h10.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.

• Brand Name: CATH TEMPO 5F VER 135 DEGREE 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS COPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14737683
• MDR Text Key: 296972281
• Report Number: 9616099-2022-05721
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032008464
• UDI-Public: (01)10705032008464(17)240930(10)18062368
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 451514H0
• Device Catalogue Number: 451514H0
• Device Lot Number: 18062368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1