MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problems Fracture (1260); Separation Failure (2547)

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

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

Telephone number is (b)(6).A device history review could not be performed since the complaint lot number is unknown.The exact lot number of the involved device could not be determined.Lots supplied to the facility include 18065386, 18078270 and 18040578.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

While removing a 5f pig 110cm 6sh supertorque catheter with marker bands from a 6f cordis sheath catheter, the doctor noticed small friction but nothing concerning.He did not use excessive force to pull out the catheter but when the catheter was out of the sheath, the physician noticed that the distal portion (of the mb) was missing, approximately 20cm from the distal end.The xray indicted that the distal part remained over the wire in the bifurcation proximally to distally in the left common femoral artery(cfa).Open left cfa exploration was preformed and cfa arthrotomy was preformed to remove the catheter.The patient is doing well and was discharged.There was no calcification, vessel tortuosity or stenosis present.The device was not resterilized.There were no anomalies noted when removed from the package and no anomalies noted during pre.The device was not inserted through a stopcock instead of a hemostatic valve.A peripheral angiography transfemoral right to left was performed.The wire was inserted to a 6f cordis sheath from the right femoral , the catheter was inserted over the wire to pass the bifurcation the catheter was placed with its tip in the left cfa, a wire exchange was preformed from one non-cordis wire to a to a stiff non-cordis wire, both 260cm in order to exchange to a long 6f sheath.There was no excessive torquing.There was no resistance met while advancing the device over the guidewire.The device did not kink in the area of separation.The lot number is not available.The device will not be returned for analysis.Procedural films were requested.

Manufacturer Narrative

While removing a 5f pig 110cm 6sh supertorque catheter with marker bands from a 6f cordis sheath, the doctor noticed small friction but nothing concerning.He did not use excessive force to pull out the catheter but when the catheter was out of the sheath, the physician noticed that the distal portion (of the mb) was missing, approximately 20cm from the distal end.The x-ray indicated the distal part remained over the wire in the bifurcation proximally to distally in the left common femoral artery(cfa).Open left cfa exploration was preformed and cfa arthrotomy was preformed to remove the catheter.The patient is doing well and was discharged.There was no calcification, vessel tortuosity or stenosis present.The device was not resterilized.There were no anomalies noted when removed from the package and no anomalies noted during use.The device was not inserted through a stopcock instead of a hemostatic valve.A peripheral angiography transfemoral right to left was performed.The wire was inserted into a 6f cordis sheath from the right femoral.The catheter was inserted over the wire to pass the bifurcation.The catheter was placed with its tip in the left cfa and a wire exchange was preformed from one non-cordis wire to a to a stiff non-cordis wire (both 260cm) to exchange for a long 6f sheath.There was no excessive torquing.There was no resistance met while advancing the device over the guidewire.The device did not kink in the area of separation.A product history record (phr) review could not be performed because the lot number for this product is unknown.Without the return of the device or images for analysis, the reported customer event ¿catheter (body/shaft)- separated-in patient¿ and ¿catheter (body/shaft)- resistance/friction - in-patient¿ could not be confirmed.Procedural factors and/or vessel characteristics factors may have contributed to the reported event.When resistance is met, the operator should take great care before applying more force during withdrawal.Magnified fluoroscopy will usually identify the point/ source of resistance.Often advancing the catheter rather retraction can resolve the issue.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.Avoid entrapment of the catheter between other endovascular devices and the vessel wall.¿ based on the information available, 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: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14345696
• MDR Text Key: 291286767
• Report Number: 9616099-2022-05616
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: 10705032012034
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K915836
• 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: 05/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 532598B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 260CM WIRE (ROADRUNNER), 260CM STIFF WIRE (COOK).
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 75 KG