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

Catalog Number	534642T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, two 6f multipurpose (mp) a2 100cm infiniti thrulumen diagnostic catheter broke during shaping.The strain relief portion of the device broke during shaping, resulting in a fracture and separation into multiple pieces.The surgeon immediately stopped using the catheters and replaced them with another non-cordis catheter to continue the procedure.There was no reported patient injury.The event occurred during a patent ductus arteriosus (pda) surgical procedure after an unknown guidewire had been removed.The device was stored and prepared according to the instructions for use (ifu).Shaping was performed outside of the patient, and the breakage also occurred outside of the patient.The devices will be returned for evaluation.The hospital reported this case as a serious injury adverse event to the china nmpa.Addendum: both devices were returned with separations at the distal tip and the strain reliefs fully intact.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, two 6f multipurpose (mp) a2 100cm infiniti thrulumen diagnostic catheter broke during shaping.The strain relief portion of the device broke during shaping, resulting in a fracture and separation into multiple pieces.The surgeon immediately stopped using the catheters and replaced them with another non-cordis catheter to continue the procedure.There was no reported patient injury.The event occurred during a patent ductus arteriosus (pda) surgical procedure after an unknown guidewire had been removed.The device was stored and prepared according to the instructions for use (ifu).Shaping was performed outside of the patient, and the breakage also occurred outside of the patient.Both catheters were returned for evaluation.A non-sterile cath f6inf tl mp a2 100cm 2sh unit was received coiled inside a clear plastic bag and unpacked for evaluation.Two units were received; one device was evaluated under this complaint and the other under a separate complaint.Visual inspection identified a separation at the brite tip/distal tip; however, the separated portion was not returned for evaluation.No other damage or anomalies were observed with the naked eye on the returned device components.Due to the condition found, amplified images of the unit were taken.Analysis of the separated area showed evidence of elongation and plastic deformation, findings commonly associated with tensile overload, indicating the material was subjected to a force beyond its yield strength prior to the observed damage.The fusion between the components showed no anomalies.Dimensional analysis of the inner diameter and outer diameter was performed near the damaged area and the results were within specification.Based on the available information and analysis, there is no evidence to suggest the reported failure is related to the manufacturing process, and no corrective or preventive actions will be taken at this time.The reported ¿brite tip/distal tip ¿ separated¿ seen during the product evaluation of both devices.The exact cause of the reported event cannot be determined.Evaluation results showed signs of tensile overload therefore, use related factors cannot be excluded.The instructions for use do not provide specific guidance regarding manual shaping or deformation of the catheter prior to insertion.The device is intended for use by trained healthcare professionals experienced in catheterization procedures, who are responsible for device handling and technique selection based on clinical judgment.Manual shaping is not defined as a device-specific instruction, requirement, or limitation within the ifu and is therefore considered an operator-dependent technique rather than a manufacturer-directed use condition.Based on the available information, there is no indication that this specific event is related to device design or the manufacturing process.Therefore, no further actions will be taken.

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 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: 24582551
• Report Number: 9616099-2026-00368
• Device Sequence Number: 18739678
• Product Code: DQO
• UDI-Device Identifier: 10705032014304
• UDI-Public: (01)10705032014304(17)280531(10)18459088
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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 Catalogue Number: 534642T
• Device Lot Number: 18459088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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 MPA2 100CM INFINITI DIAGNOSTIC CATHETER.; UNKNOWN CATHETER.; UNKNOWN GUIDEWIRE.
• Patient Age: 69 YR
• Patient Sex: Female