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

Catalog Number XXXXXXX

Device Problem Structural Problem (2506)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Notification of field action - super torque mb.As reported by a double-blinded survey, the unknown pigtail with markers diagnostic catheter had huge problems with markers moving and catheter body breaking.They never used it anymore.There was no reported patient injury.The device will not be returned for evaluation.Without a lot number to conduct a device history record (dhr) review, it is not possible to determine if the reported failure could be related to the manufacturing process.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.According to the instruction for use (ifu), cordis angiographic catheters with marker bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.The ifu instructs the user to treat all devices with ultimate care as the performance of these products may be impaired if not properly and cautiously handled.The ifu cautions the user to not use any device that is damaged.Without a lot number to conduct a device history record (dhr) review, it is not possible to determine if the reported failure could be related to the manufacturing process.However, a risk assessment has been initiated to escalate and further investigate this issue.

Event Description

As reported by a double-blinded survey, the unknown pigtail with markers diagnostic catheter had huge problems with markers moving and catheter body breaking.They never use it anymore.There was no reported patient injury.The device will not be returned for evaluation.

• Brand Name: UNKNOWN DIAGNOSTIC CATHETER CARDIOLOGY
• 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: 12203746
• MDR Text Key: 262687770
• Report Number: 9616099-2021-04718
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXXXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• 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