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

Model Number 532598B

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.The device was received for analysis but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 5f 6 side holes (sh) 110cm super torque marker band (mb) pigtail catheter (cath mb 5f pig 110cm 6sh) broke off into two halves during retrieval from the patient.The catheter was still along a guidewire and was able to be completely retrieved from the patient.There was no reported patient injury.The device was being used in an endovascular aneurysm repair (evar).The target lesion was the abdominal aorta.The lesion calcification, tortuosity and per-cent stenosis are unknown.The device was not being used for a chronic total occlusion (cto).The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when the product was removed from the package.The product was inspected and prepped according to the ifu.It was flushed with saline.There was no difficulty experienced in prepping the device.There was no resistance/friction experienced during any part of the procedure nor any resistance while advancing the device.No unusual force was needed during use of the device nor excessive torquing required.The mid shaft of the sizing catheter separated.When the sizing pigtail separated, the physician was able to gently pull back the guidewire, as the 0.035 guidewire was inside the sizing pigtail.The tip was visible on fluoroscopy throughout the procedure.The device was not resterilized.There was no difficulty experienced when removing the product from the patient.The procedure was completed by using x-ray qca method instead using a calibration catheter.The patient was reported to be recovering and healthy and was not hospitalized or required extended hospitalization as a result of this event.The device is expected to be return for evaluation.Two images provided were reviewed and show what appear to be jagged edges of a separated catheter.

Manufacturer Narrative

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

Manufacturer Narrative

As reported, the 5f 6 side holes (sh) 110cm super torque marker band (mb) pigtail catheter (cath mb 5f pig 110cm 6sh) broke off into two halves during retrieval from the patient.The catheter remained on the guidewire and was able to be completely retrieved from the patient.There was no reported patient injury.The device was being used in an endovascular aneurysm repair (evar).The target lesion was the abdominal aorta.Vessel characteristics are unknown.The device was not being used for a chronic total occlusion (cto).The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when the product was removed from the package.The product was inspected and prepped according to the ifu.It was flushed with saline.There was no difficulty experienced in prepping the device.There was no resistance/friction experienced during any part of the procedure nor any resistance while advancing the device.No unusual force was needed during use of the device and excessive torquing was not required.The mid shaft of the sizing catheter separated.When the sizing pigtail separated, the physician was able to gently pull back the guidewire, as the 0.035 guidewire was inside the sizing pigtail.The tip was visible on fluoroscopy throughout the procedure.The device was not resterilized.There was no difficulty experienced when removing the product from the patient.The procedure was completed by using x-ray qca method instead of using a calibration catheter.The patient was reported to be recovering and healthy, was not hospitalized and did not require an 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 with ten out of the twenty marker bands moved/out of position at the distal section of the unit.Additionally, a separated condition was noted approximately 24.5 cm from distal tip.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Microscopic analysis of the moved marker bands was performed, and no anomalies were observed.Sem analysis of the separated area of the body/shaft presented evidence of elongations and a scratch mark on the body/shaft material of the unit.A product history record (phr) review of lot 17918288 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: 13953665
• MDR Text Key: 294797439
• Report Number: 9616099-2022-05492
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: 10705032012034
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17918288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• 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 0.035 GUIDEWIRE.