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 02/22/2022

Event Type  Injury  

Manufacturer Narrative

A review of the device history record (dhr) revealed no anomalies during the manufacturing and inspection processes that can be associated with the event reported.The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during an aortic stenting procedure, a calibration catheter, a 5f 100cm 6 side holes (6sh) super torque marker band (mb) diagnostic catheter was used.The catheter broke during removal and the broken piece was removed using the ¿lasso¿ technique with increased blood loss and risk of aortic stent migration.There was no reported patient injury.The device is expected to be return for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

An aortic stenting was being performed on a male patient.Lesion calcification, vessel tortuosity and percentage stenosis are unknown.It is unknown if the device was used for a chronic total occlusion.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no resistance while advancing the device.There was resistance/friction experienced during removal.No unusual force was necessary during use of the device.It is unknown if excessive torquing was required.The segment was retrieved using lasso technique and the procedure was then completed normally.The patient was not hospitalized nor required extended hospitalization because of this event.

Manufacturer Narrative

The device was received for evaluation.Engineering report is in process.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, a 5f 100cm 6 side holes (6sh) super torque marker band (mb) diagnostic catheter was used during an aortic stenting procedure.The catheter separated during removal and the retained portion was removed using a ¿lasso¿ technique with increased blood loss and risk of aortic stent migration.There was no reported patient injury.The procedure was performed on a male patient.Lesion calcification, vessel tortuosity and percentage stenosis are unknown.It is unknown if the device was used for a chronic total occlusion.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no resistance while advancing the device.There was resistance/friction experienced during removal.No unusual force was necessary during use of the device.It is unknown if excessive torquing was required.The procedure was completed after removal of the retained catheter section.The patient was not hospitalized nor required extended hospitalization because of this event.One non-sterile cath mb 5f pig 110cm 6sh unit was received for analysis.During visual inspection, the unit presented fourteen out of the twenty marker bands moved/out of position at the distal section of the unit.Additionally, a separated condition was noted approximately at 25 cm from 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.Microscopic analysis was performed with no anomalies were observed.Sem analysis of the separated area presented evidence of elongations and scratch mark on the body/shaft material of the unit.A product history record (phr) review of lot 18053806 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 ¿catheter (body/shaft) ¿ separated - in-patient¿ was confirmed since a separated condition was noted on the unit.Marker bands were also noted to be offset/out of position.The elongations found on the body/shaft of the unit 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 scratch mark near separation suggests the unit was torn by exposure to a sharp object.The exact cause of these finding could not be conclusively determined during this analysis.Manipulation of the catheter under excessive friction or an interaction between the body/shaft of the catheter and a sharp medical instrument/device may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.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), 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 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: 13826390
• MDR Text Key: 287527292
• Report Number: 9616099-2022-05467
• 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: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 18053806
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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
• Treatment: UNKNOWN.
• Patient Outcome(s): Life Threatening
• Patient Age: 83 YR
• Patient Sex: Male