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

Model Number 532598B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

The product history record (phr) review of lot 18067212 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that could be associated with the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the probe of a 5f 110cm 6 side holes (sh) super torque pigtail marker band (mb) angiographic catheter was torn, and the radiolabeled rings became loose but not inside the patient.The device was used in the identification phase of the left iliac leg during endoprosthesis for an aneurysm of the abdominal aorta.The probe therefore had to be withdrawn through the skin after removal of the sheath introducer and very likely damaged the percutaneous closure system.At the end of the procedure, there was failure of the percutaneous closure and occurrence of hemorrhage, for which prolonged manual compression was required, "aggressive" pressure dressing with ¿scarpa ¿and armed surveillance in intensive care in addition to echo control doppler at d+1 without particularity.Note that the practitioner is aware of safety information r2123558, the device was only used in the identification phase of the left iliac leg (not a priority risk of the catheter being stuck between the endovascular devices and the vascular wall as mentioned in the alert).The device was being used for an abdominal aorta aneurysm and a left iliac approach was used.Vessel calcification, tortuosity and stenosis are unknown.The device was not being used for a chronic total occlusion.The catheter body shaft in addition to the opaque marker rings became separated.There were no anomalies noted when the product was removed from the package.The product was stored, handled, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.It is unknown if there was resistance while advancing the device; if resistance friction was experienced during any part of the procedure and if unusual force was necessary during use of the device.It is also unknown if the event caused a clinically relevant increase in the duration of the procedure or if the event caused a condition that required hospitalization or significant prolongation of existing hospitalization.

Manufacturer Narrative

As reported, the probe of a 5f 110cm 6 side holes (sh) super torque pigtail marker band (mb) angiographic catheter was torn, and the radiolabeled rings became loose but not inside the patient.The device was used in the identification phase of the left iliac leg during endoprosthesis for an aneurysm of the abdominal aorta.The probe therefore had to be withdrawn through the skin after removal of the sheath introducer and very likely damaged the percutaneous closure system.At the end of the procedure, there was failure of the percutaneous closure and occurrence of hemorrhage, for which prolonged manual compression was required, "aggressive" pressure dressing with ¿scarpa ¿and armed surveillance in intensive care in addition to echo control doppler at d+1 without particularity.Note that the practitioner is aware of safety information r2123558, the device was only used in the identification phase of the left iliac leg (not a priority risk of the catheter being stuck between the endovascular devices and the vascular wall as mentioned in the alert).The device was being used for an abdominal aorta aneurysm and a left iliac approach was used.Vessel calcification, tortuosity and stenosis are unknown.The device was not being used for a chronic total occlusion.The catheter body shaft in addition to the opaque marker rings became separated.There were no anomalies noted when the product was removed from the package.The product was stored, handled, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.It is unknown if there was resistance while advancing the device; if resistance friction was experienced during any part of the procedure and if unusual force was necessary during use of the device.It is also unknown if the event caused a clinically relevant increase in the duration of the procedure or if the event caused a condition that required hospitalization or significant prolongation of existing hospitalization.One non-sterile cath mb 5f pig 110cm 6sh unit was received for analysis.During visual inspection, the marker bands were observed moved out of position.Seventeen of the twenty marker bands were offset at the proximal section.Additionally, a separated condition was noted approximately 25.3 cm from the distal tip.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Functional analysis could not be performed due the separated condition.Amplified microscopic images of the moved marker bands were taken and no anomalies were observed.Sem analysis presented evidence of elongations and cup and cone like shape on the body/shaft of the unit.A product history record (phr) review of lot 18067212 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿marker band (supertorque) ¿ offset/out of position - in-patient¿ was confirmed.The marker bands were observed moved on the unit.The event reported by the customer as ¿catheter (body/shaft) ¿ separated - in-patient¿ was confirmed.A separated condition was noted on the unit.The elongations and cup and cone shape found on the body/shaft and the braidwire are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the body/shaft material yield strength prior to the separation.The exact cause of the conditions found could not be conclusively determined during the analysis.Patient vessel characteristics may have created withdrawal difficulties, which led to the elongations and subsequent separation.Although not intended as a mitigation of risk, information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), ¿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 and the phr 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: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 14452969
• MDR Text Key: 292224885
• Report Number: 9616099-2022-05643
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: 10705032012034
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 18067212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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