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

Model Number 451514H0

Device Problem Crack (1135)

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

Event Date 08/31/2021

Event Type  malfunction  

Event Description

As reported, a 5f vertebral 135-degree 100cm tempo catheter was unusable because it was cracked.There was no reported patient injury.The intended procedure was a coronary angioplasty.The damage noticed during prep.The product was stored and handled according to the instructions for use (ifu).There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The procedure was completed with another device.The device will not be returned for evaluation as it was discarded.

Manufacturer Narrative

Complaint conclusion: as reported, a 5f vertebral 135-degree 100cm tempo catheter was unusable because it was cracked.There was no reported patient injury.The intended procedure was a coronary angioplasty.The damage was noticed during prep.The product was stored and handled according to the instructions for use (ifu).There was no damage to the device noticed prior to opening the package and no difficulties were encountered while removing the device from its sterile packaging.The procedure was completed with another device.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 17987184 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 ¿catheter (body/shaft)- cracked¿ could not be confirmed.Shipping/handling factors 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, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Exposure to temperatures above 54°c (130°f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and gently 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.

• 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 CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12796440
• MDR Text Key: 285169830
• Report Number: 9616099-2021-05049
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032008461
• UDI-Public: (01)20705032008461(17)231031(10)17987184
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 451514H0
• Device Catalogue Number: 451514H0
• Device Lot Number: 17987184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2020
• 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