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

Catalog Number 534642T

Device Problem Crack (1135)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

As reported, a 6f infiniti 100cm multipurpose 2 side holes (mpa2sh) diagnostic catheter was found to be fractured in the preoperative preparation of the angiography catheter, which was removed and straighten and prepared for use.The device is expected to be returned for evaluation.The hospital reported it as an adverse event to the china nmpa directly.Please upgrade this case to ae.

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.

• 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18584143
• MDR Text Key: 334787064
• Report Number: 9616099-2024-00031
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032014304
• UDI-Public: 10705032014304
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 534642T
• Device Lot Number: 18219125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2024
• 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