MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F UF 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 451404V5

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.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.

Event Description

As reported, during a superficial femoral recanalization in crossover, the end of the tempo catheter (cath tempo 4f uf 65cm 5sh) detached intra-arterially and it was retrieved by the surgeon using a lasso probe.There was no reported patient injury.Another sterile tempo catheter was opened.The target lesion was the femoral artery and the intended.Vessel calcification, tortuosity and percentage stenosis are unknown.The intended procedure was reported to be a superficial femoral recanalization in crossover.It is unknown if the device was being used for a chronic total occlusion.The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when the product was removed from the package.The product was inspected and prepped according to the ifu and there was no difficulty experienced in prepping the device.The device was not inserted through a stopcock instead of a hemostatic valve.It is unknown if there was resistance met while advancing the device.No unusual force was necessary during use of the device, and it is unknown if torqueing was required.It is also unknown which part of the device separated or if the tip was visible on fluoroscopy throughout the procedure.The device was not resterilized.It is not known if there was any difficulty experienced when removing the product from the patient, from the vessel or through another device.The surgeon retrieved the device with a lasso probe and utilized another sterile tempo catheter.The patient was not hospitalized nor required extended hospitalization because of the event.

Manufacturer Narrative

As reported, during a superficial femoral recanalization in crossover, the end of the 4f uf 65cm 5 side holes tempo catheter detached intra-arterially.It was retrieved by the surgeon using a lasso probe.There was no reported patient injury.Another sterile tempo catheter was opened to complete the procedure.The target lesion was the femoral artery and the intended location.Vessel calcification, tortuosity and percentage stenosis are unknown.The intended procedure was reported to be a superficial femoral recanalization in crossover.It is unknown if the device was being used for a chronic total occlusion (cto).The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when the product was removed from the package.The product was inspected and prepped according to the ifu, and there was no difficulty experienced while prepping the device.The device was not inserted through a stopcock instead of a hemostatic valve.It is unknown if there was resistance met while advancing the device.No unusual force was necessary during use of the device, and it is unknown if torquing was required.It is also unknown which part of the device separated or if the tip was visible on fluoroscopy throughout the procedure.The device was not resterilized.It is not known if there was any difficulty experienced when removing the product from the patient, from the vessel or through another device.The surgeon retrieved the device with a lasso probe and utilized another sterile tempo catheter.The patient was not hospitalized nor required extended hospitalization because of the event.The device was returned for analysis.One non-sterile cath tempo 4f uf 65cm 5sh unit was received for analysis inside a plastic bag.The device was unpacked to proceed with the product evaluation.During visual inspection, a separated condition was observed located approximately at 61.4 cm from the hub.The other separated portion of the unit was not returned for analysis.No other anomalies could be observed to the naked eye.Due the separated condition of the received unit, an sem analysis was performed.Results showed the separated area of the body/shaft of the cath tempo 4f uf 65cm 5sh unit presented evidence of elongations and scratch marks on the body/shaft material of the unit.No other anomalies were observed.The elongations found on the body/shaft material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is likely that the body/shaft material was induced to a tensile force that exceeded the body/shaft material¿s yield strength prior to the separation.Also, the scratch marks near the separated area suggests that the unit was torn with a sharp object from outside of the unit.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 18053427 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip separated in patient¿ was confirmed through analysis of the returned device.However, the exact root cause could not be determined.Based on the information available for review and the product analysis, target lesion characteristics (although not provided) and/or handling factors (such as excessive force) likely contributed to the catheter separation reported as evidenced by the signs of elongations and scratch marks noted during sem analysis.These conditions are commonly associated with separations caused by material tensile overload and interaction with a sharp object.As provided in the information for safety within the instructions for use (ifu), ¿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.¿ the ifu also states, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ neither the product analysis, nor the phr or information available for review suggest that the reported issue could be related to the design or manufacturing process.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: CATH TEMPO 4F UF 65CM 5SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 13966597
• MDR Text Key: 288388008
• Report Number: 9616099-2022-05495
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 451404V5
• Device Lot Number: 18053427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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