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

Catalog Number	534618T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, when the physician removed the 6f judkin's left (jl) 3.5 100 cm tl infiniti diagnostic catheter from the patient, it was separated in two pieces, with one portion left in the patient's arm.The physician had to use a snare to remove the piece that was broken off causing a delay in procedure.There were no additional reports of patient injury.Six devices of the same lot will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, when the physician removed the 6f judkin's left (jl) 3.5 100 cm tl infiniti diagnostic catheter from the patient, it was separated in two pieces, with one portion left in the patient's arm.The physician had to use a snare to remove the piece that was broken off causing a delay in procedure.There were no additional reports of patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18382245 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint "brite tip/distal tip separated" could not be evaluated.The exact cause could not be determined.Factors such as vessel anatomy, user handling, and concomitant devices could be a contributing factor additional force and manipulation of the catheter may have also been a contributing factor the reported event.All catheters require torquing, which is a dynamic process once it enters the patient due to external factors such as temperature, time of exposure in body, individual patient anatomical structures, storage conditions, and operator technique in torquing and manipulating the catheter.If a catheter does not move as expected, the operator is trained to stop and investigate the cause before continuing to avoid further damage to the catheter, such as a separation.Based on the device history record 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: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 21526268
• Report Number: 9616099-2025-00344
• Device Sequence Number: 8339506
• Product Code: DQO
• UDI-Device Identifier: 10705032014168
• UDI-Public: (01)10705032014168(17)270930(10)18382245
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 534618T
• Device Lot Number: 18382245
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F TERUMO SLENDER.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown