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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18058027 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the super torque mb 5f 110cm pig catheter became separated 21.5cm from the distal tip during the procedure while in the patient.The device was removed with a gooseneck snare and the case was completed.There was no reported injury to the patient.There was no damage to the package and no anomalies noted to the device when removed from the package.The device was prepped per the instructions for use (ifu) with no difficulty experienced.The femoral artery was used for access.There was no resistance noted while the catheter was advanced through the sheath.Excess force was not used or needed.The catheter advanced through the vasculature without difficulty.The vessel was noted to have moderate tortuosity and the lesion had moderate calcification.The device will be returned for evaluation.Addendum: image received was reviewed and demonstrates a pigtail catheter with marker bands.There is a separation noted to the body/shaft.A secondary failure was found "marker band (supertorque) offset/out of position.".

Manufacturer Narrative

As reported, the super torque mb 5f 110cm pig catheter separated 21.5cm from the distal tip while in the patient.The device was removed with a gooseneck snare and the case was completed.There was no reported patient injury.No damages to the package or anomalies were noted to the device when it was removed from the package.The device was prepped per the instructions for use (ifu) with no difficulty experienced.The femoral artery was used for access.There was no resistance noted while the catheter was advanced through the sheath.Excess force was not used or needed.The catheter advanced through the vasculature without difficulty.The vessel was noted to have moderate tortuosity and the lesion had moderate calcification.One non-sterile ¿cath mb 5f pig 110cm 6sh¿ was received for analysis.A separation located 24.5 cm from the distal tips was observed.The unit also presents with markers bands 17,19 and 20 out of position (the marker bands are numerated from the distal end to the hub).All 20 marker bands remain on the body of the catheter.Inner diameter (id) and outer diameter (od) measurements were taken near the areas where the marker bands are out of position.Results were found below the lower specification and indicate the unit is elongated.Measurements were also taken one cm from the separated edges of the catheter.The diameter measured below the lower specification, which also indicates elongation of the catheter.Functional analysis was performed by inserting an 0.038¿ lab sample guidewire inside the catheter via the distal tip.The guide wire could not be passed through the catheter.This was due to the reduced inner diameter.The marker bands were inspected with a vision system in order of obtain a magnified image and no anomalies or damages were observed.Sem results of the separated area presented evidence of elongations and a cup and cone like shape on the body/shaft of the unit.Plastic deformations located at the separated area were observed on the braid wire.A product history record (phr) review of lot 18058027 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint ¿catheter (body/shaft) ~ separated - in-patient¿ was confirmed.The unit was returned separated in two pieces.The marker bands of the catheter were also observed offset/out of position.The exact cause of this condition could not be conclusively determined during the analysis.Plastic deformations, elongation and cup and cone failures are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the catheter was induced to a tensile force that exceeded its material yield strength prior to the separation.Procedural factors such as vessel characteristics or entrapment of the catheter between other endovascular devices and the vessel wall may have contributed to this issue.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.

Event Description

As reported, the super torque mb 5f 110cm pig catheter became separated 21.5cm from the distal tip during the procedure while in the patient.The device was removed with a gooseneck snare and the case was completed.There was no reported injury to the patient.There was no damage to the package and no anomalies noted to the device when removed from the package.The device was prepped per the instructions for use (ifu) with no difficulty experienced.The femoral artery was used for access.There was no resistance noted while the catheter was advanced through the sheath.Excess force was not used or needed.The catheter advanced through the vasculature without difficulty.The vessel was noted to have moderate tortuosity and the lesion had moderate calcification.The device will be returned for evaluation.Addendum: image received was reviewed and demonstrates a pigtail catheter with marker bands.There is a separation noted to the body/shaft.A secondary failure was found "marker band (supertorque) ~ offset/out of position".

• 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: 13618710
• MDR Text Key: 286583992
• Report Number: 9616099-2022-05358
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: (01)10705032012034(17)240930(10)18058027
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• 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: 18058027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2021
• 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): Other; Required Intervention