MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F UF 90CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 451404F5

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

As reported, before use in patient, the physician realized the tip of diagnostic tempo guide catheter (4f uf 90cm 5sh) was broken.There was no reported patient injury.The device was stored in the lab as per instructions for use (ifu).The device was stored and handled per the ifu.There was no damage noted to the package.There were no anomalies noted when removed from the package.There was no excessive force applied to the device during withdrawal from package.The integrity of the sterile pouch was not compromised.The product was purposely opened in anticipation of use.The device was prepped according to instructions for use (ifu).There were no kinks noted on the device prior to use.The product was not used in the patient.One non-sterile cath tempo 4f uf 90cm 5sh catheter was received for analysis inside a plastic bag.Per visual analysis, the tip of the unit was received damaged.The distal tip of catheter was inspected under vision system and observed frayed/split damaged.No other anomalies found.The device was sent for scanning electron microscope (sem) analysis to identify the cause of the damaged found on tip.Sem analysis results showed that the catheter tip presented a frayed/split condition and evidence of material deformation and elongation.Elongation is a common characteristic of pieces which were stretched / pulled until separation.No evidence of scratching or abrasion was observed.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17638701 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.As additional information, controls are in place to verify the diagnostic catheters for any type of damages on units; the produced catheters are final inspected before leaving the facility.Also, several inspections are performed through all the diagnostic catheters assembly process operations.The reported ¿brite tip/distal tip-damaged¿ was confirmed through analysis of the returned device since a frayed/spit/torn condition was noted.However, the exact cause of the frayed/split damage could not be conclusively determinate during the analysis.Based on the limited information available for review, handling factors likely contributed to the frayed/split condition reported as evidenced by the material deformation and elongations noted during sem analysis.According to the instructions for use, which is not intended as a mitigation, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, before use in patient, the physician realized the tip of diagnostic tempo guide catheter (4f uf 90cm 5sh) was broken.There was no reported patient injury.The device was stored in the lab as per instructions for use (ifu).The device was stored and handled per the ifu.There was no damage noted to the package.There were no anomalies noted when removed from the package.There was no excessive force applied to the device during withdrawal from package.The integrity of the sterile pouch was not compromised.The product was purposely opened in anticipation of use.The device was prepped according to instructions for use (ifu).There were no kinks noted on the device prior to use.The product was not used in the patient.Additional information was received indicating that during the analysis of the product it was noted that the distal tip of catheter was frayed/split /torn.

• Brand Name: CATH TEMPO 4F UF 90CM 5SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6908821
• MDR Text Key: 89526030
• Report Number: 9616099-2017-01477
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 451404F5
• Device Lot Number: 17638701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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