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

Catalog Number	SRD6109
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
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, during an interventional angiogram performed in the north zone, it was noted intraoperatively under angiography that the proximal end of the catheter was kinked.When the proximal catheter was turned, the distal end could not be turned with it.The kinked catheter could not be withdrawn at that time, and attempts were made to rotate the catheter in both directions while trying to withdraw the kinked catheter by untwisting it using a guidewire.There were no reports of patient injury.The hospital reported this case as a serious injury adverse event to china nmpa.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, during an interventional angiogram performed in the north zone, it was noted intraoperatively under angiography that the proximal end of the 5f 125cm tempo aqua diagnostic catheter was kinked.When the proximal catheter was turned, the distal end could not be turned with it.The kinked catheter could not be withdrawn at that time, and attempts were made to rotate the catheter in both directions while trying to withdraw the kinked catheter by untwisting it using a guidewire.There were no 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: 18362762 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 ¿catheter (body/shaft) kinked/bent and catheter (body/shaft) withdrawal difficulty from vessel¿ could not be evaluated.With the limited information provided, without the return of the device, and with no procedural films, the cause of the reported event could not be determined.It is possible that factors related to the procedure, handling, and/or patient anatomy contributed to the reported event.The kink experienced probably led to the difficulty to remove the catheter 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.Based on the information available for review, there is no indication to suggest that the reported incident could be related to the design or manufacturing process of the units.No preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported, during an interventional angiogram performed in the north zone, it was noted intraoperatively under angiography that the proximal end of the 5f 125cm tempo aqua diagnostic catheter was kinked.When the proximal catheter was turned, the distal end could not be turned with it.The kinked catheter could not be withdrawn at that time, and attempts were made to rotate the catheter in both directions while trying to withdraw the kinked catheter by untwisting it using a guidewire.The procedure was completed by switching to a new angiography catheter using a contralateral approach.There were no reports of patient injury.Vessel characteristics at the target site and access site showed no calcification, tortuosity, stenosis, acute angles, or bifurcation.The device was not pulled from the packaging by the hub nor torqued or steered by it.Withdrawal difficulty was encountered when withdrawing from the vessel but not through the sheath.The catheter was not entrapped during the procedure.No damages were observed on the device or its packaging before opening.The device was stored and prepped according to the instructions for use (ifu).The user was trained in the use of the device.The hospital reported this case as a serious injury adverse event to china nmpa.The product was disposed of and therefore not returned.
Additional Manufacturer Narrative
Supplemental fda report was successfully submitted to the fda on 08-aug-2025.
Additional Manufacturer Narrative
Complaint conclusion: as reported, during an interventional angiogram performed in the north zone, it was noted intraoperatively under angiography that the proximal end of the 5f 125cm tempo aqua diagnostic catheter was kinked.When the proximal catheter was turned, the distal end could not be turned with it.The kinked catheter could not be withdrawn at that time, and attempts were made to rotate the catheter in both directions while trying to withdraw the kinked catheter by untwisting it using a guidewire.The procedure was completed by switching to a new angiography catheter using a contralateral approach.There were no reports of patient injury.Vessel characteristics at the target site and access site showed no calcification, tortuosity, stenosis, acute angles, or bifurcation.The device was not pulled from the packaging by the hub nor torqued or steered by it.Withdrawal difficulty was encountered when withdrawing from the vessel but not through the sheath.The catheter was not entrapped during the procedure.No damages were observed on the device or its packaging before opening.The device was stored and prepped according to the instructions for use (ifu).The user was trained in the use of the device.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18362762 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 ¿catheter (body/shaft) kinked/bent and catheter (body/shaft) withdrawal difficulty from vessel¿ could not be evaluated.With the limited information provided, without the return of the device, and with no procedural films, the cause of the reported event could not be determined.It is possible that factors related to the procedure, handling, and/or patient anatomy contributed to the reported event.The kink experienced probably led to the difficulty to remove the catheter 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.Based on the information available for review, there is no indication to suggest that the reported incident could be related to the design or manufacturing process of the units.No preventative or corrective actions will be taken at this time.

• Brand Name: ENDO DIAGNOSTIC CATHETER
• 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: 22322273
• Report Number: 9616099-2025-01023
• Device Sequence Number: 18379649
• Product Code: DQO
• UDI-Device Identifier: 10705032049795
• UDI-Public: (01)10705032049795(17)270731(10)18362762
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000579
• 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,Followup,Followup
• Report Date (Section B): 08/11/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: SRD6109
• Device Lot Number: 18362762
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 07/13/2025; 08/10/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/25/2025; 08/08/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2024
• 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: UNKNOWN GUIDEWIRE.
• Patient Age: 80 YR
• Patient Sex: Male