MAUDE Adverse Event Report: CORDIS US CORP. INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 534521T

Device Problem Material Puncture/Hole (1504)

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

As reported, a hole was found midway down a 5f 100 cm infiniti judkins right (jr4) diagnostic catheter when opened.The packaging was intact.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).An angiography was reported to be the intended procedure.The device is expected to be returned for investigation.

Manufacturer Narrative

The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, a hole was found midway down a 5f 100 cm infiniti judkins right (jr4) diagnostic catheter when opened.The packaging was intact.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).The intended procedure was an angiogram.One non-sterile cath f5 inf jr 4 100cm catheter was received for analysis.During visual inspection, no punctures or kinked/bent sections were observed on the received device.The device was inspected for damages/anomalies that may have contributed to the reported failure and none were observed.Visual inspection at high magnification confirmed the absence of punctures or kinked/bent on the catheter or the distal tip.The reported "catheter (body/shaft)-puncture/cut" was not confirmed.No damages were found on the returned device and the exact cause of the reported event could not be determined.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 available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.

Manufacturer Narrative

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.

• Brand Name: INFINITI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18501508
• MDR Text Key: 332745150
• Report Number: 9616099-2024-00013
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032013697
• UDI-Public: 10705032013697
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970854
• 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
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 534521T
• Device Lot Number: 18241668
• 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: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2023
• 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: (B)(6) 2023.