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

Catalog Number 451514H0

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/08/2023

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18066064 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 Description

As reported, a 5f 135-degree 100 cm vertebral tempo catheter broke in the blood vessel and was removed after capture.A new angiography catheter was used to complete the procedure.There were no reports of patient injury.The femoral artery was punctured, the catheter was advanced along the unknown guidewire.The contrast catheter was broken during 1.5 turns of torsion-controlled rotation along the guidewire in the vessel.After the device fractured, a capture device was used to grasp out and replace the contrast tube for imaging.The target site vessel was mildly calcified, mildly tortuous and there was 80% stenosis.However, there was no bifurcation or acute angulation of the target site vessel.There was no calcification, tortuosity, acute angulation, or bifurcation of the access site vessel.The device was pulled from the packaging by the hub.The device was not torqued or ¿steered¿ by the hub.There were no difficulties inserting or advancing the catheter.The catheter was inserted along the guidewire during the twist control.The user was trained in the use of the device.The male patient weighed 75kg and was undergoing neurosurgery for whole brain imaging.This was a routine operation.The device will be returned for evaluation.

Manufacturer Narrative

As reported, a 5f 135-degree 100 cm vertebral tempo catheter broke in the blood vessel and was removed after capture.A new angiography catheter was used to complete the procedure.There were no reports of patient injury.The femoral artery was punctured, the catheter was advanced along the unknown guidewire.The contrast catheter was broken during 1.5 turns of torsion-controlled rotation along the guidewire in the vessel.After the device fractured, a capture device was used to grasp out and replace the contrast tube for imaging.The target site vessel was mildly calcified, mildly tortuous and there was 80% stenosis.However, there was no bifurcation or acute angulation of the target site vessel.There was no calcification, tortuosity, acute angulation, or bifurcation of the access site vessel.The device was pulled from the packaging by the hub.The device was not torqued or ¿steered¿ by the hub.There were no difficulties inserting or advancing the catheter.The catheter was inserted along the guidewire during the twist control.The user was trained in the use of the device.The male patient weighed 150 pounds and was undergoing neurosurgery for whole brain imaging.This was a routine operation.A non-sterile unit of ¿cath tempo 5f ver 135° 100cm¿ was received for analysis.During visual inspection a separation was observed approximately 38 cm from the proximal end.The separated piece was not returned for analysis.No other damages or anomalies were observed.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Sem analysis was not performed because the damages associated with the separation are visible with the magnification obtained with a vision system.Vision system analysis of the separated area presented evidence of elongations along the body/shaft as well as plastic elongations and deformations along the separated edges.Additionally, diameter reduction and plastic deformations were noted on the braidwire.A product history record (phr) review of lot 18066064 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿catheter body/shaft-separated¿ was confirmed.The unit was returned separated in two pieces.Elongations, plastic deformations, and diameter reduction are commonly caused by material tensile/twist overload.Therefore, it is assumed that the material was induced to tensile/twist forces that exceeded the material yield strength prior to the separation.Procedural/handling factors are a likely cause of 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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ 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

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: TEMPO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14021 nw 60 avenue; miami lakes, florida 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: 17069467
• MDR Text Key: 316665120
• Report Number: 9616099-2023-06513
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032008464
• UDI-Public: (01)10705032008464(17)241031(10)18066064
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 451514H0
• Device Lot Number: 18066064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• 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
• Treatment: ABBOTT'S VASCULAR SUTRAX; UNKNOWN CATHETER SHEATH; UNKNOWN GUIDEWIRE; YIXINDA'S 5F CONTRAST CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male