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 12/08/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.No product was received for analysis, instead 4 pictures related to the reported failure was received.As part of picture 1 &2, it can be observed a pigtail catheter inserted into a guidewire.A separation can be noticed as part of the pictures.No other anomalies of the product can be noticed at the attached pictures.This device is available for analysis but has not yet been received.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, a 5f marker band 110cm 6sh pigtail catheter was used during aortogram.As contrast was injected, the catheter snapped into two pieces.A snare was used to retrieve the distal tip section which separated from the catheter.A second 5f marker band 110cm 6sh pigtail catheter was used and it was noted that the markers were moving.Then a third 5f marker band 110cm 6sh pigtail catheter was used to complete the case and when it was removed, it was noted that the proximal marker had also moved.Fortunately, no patient injury or complication was reported.The devices were prepped per the instructions for use (ifu).There was no vessel tortuosity.The device was not used for a chronic total occlusion (total occlusion >3 months).The devices were not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The devices were not inserted through a stopcock instead of a hemostatic valve.There was no difficulty advancing the devices to the target lesion.Excessive torqueing was not required.Resistance was not met while advancing the devices over the guidewire.The devices did not pass through any acute bends.There was no difficulty crossing the lesion.The first catheter did not kink in the area of separation.Resistance was not met while withdrawing any of the devices.The distal end of the device separated approximately 20cm from the distal end.All of the marker bands were retrieved from the patient and accounted for.Several images were received for review.Image 1 and image 2: procedure table, catheter with marker bands appearing offset/out of position over a guidewire.Guidewire is extending through a straight catheter with no hub or pigtail seen.Image 3: catheter with marker bands appearing offset out of position.Image 4: distal portion of a pigtail catheter with marker bands.At least one marker band appears offset/out of position.The devices are expected to be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, a 5f marker band 110cm 6sh pigtail catheter was used during an aortogram.As contrast was injected, the catheter snapped into two pieces.A snare was used to retrieve the distal tip section which separated from the catheter.A second 5f marker band 110cm 6sh pigtail catheter was used and it was noted that the markers were moving.Then a third 5f marker band 110cm 6sh pigtail catheter was used to complete the case and when it was removed, it was noted that the proximal marker had also moved.Fortunately, no patient injury or complication was reported.The devices were prepped per the instructions for use (ifu).There was no vessel tortuosity.The device was not used for a chronic total occlusion (total occlusion >3 months).The devices were not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The devices were not inserted through a stopcock instead of a hemostatic valve.There was no difficulty advancing the devices to the target lesion.Excessive torqueing was not required.Resistance was not met while advancing the devices over the guidewire.The devices did not pass through any acute bends.There was no difficulty crossing the lesion.The first catheter did not kink in the area of separation.Resistance was not met while withdrawing any of the devices.The distal end of the device separated approximately 20cm from the distal end.All the marker bands were retrieved from the patient and accounted for.Four images were received for analysis prior to receiving the returned devices.A separated pigtail catheter with a wire inserted into it was noted in 2 of the images.The other two images revealed a pigtail catheter with marker bands moved out of their original position.During visual inspection, the marker bands on the device were observed offset/out of position, the unit presented four out of the twenty marker bands offset/out of position at the distal section of the unit.Additionally, a separated condition was noted 24.8 cm from the distal tip.No other anomalies were observed during the analysis.Inner diameter and outer diameter measurements were found within specification.Sem analysis presented evidence of elongations and flared condition on the body/shaft material of the unit.A product history record (phr) review of lot 18037277 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported on the first device ¿brite tip/distal tip ¿ separated - in-patient¿ was confirmed since a separated condition was noted on this device.Elongations and the flared condition 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 event reported on the other two devices ¿marker band (supertorque) ¿ offset/out of position - in-patient¿ was confirmed since the marker bands were found offset/out of position.The od was closer to the lower limit on both returned devices, indicating that the device could be affected by a stretching or pulling force causing the movement of the marker bands.Procedural/handling factors such as 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.

• 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: 13142546
• MDR Text Key: 283095978
• Report Number: 9616099-2022-05242
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: (01)10705032012034(17)240630(10)18037277
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• 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: 18037277
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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
• Patient Sex: Male