MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598C

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem Cardiac Arrest (1762)

Event Date 10/26/2022

Event Type  Death  

Event Description

As reported, a 5f 65cm 8sh pig tail super torque mb angiographic catheter which had been mounted on an unknown guidewire and a 14f non-cordis introducer sheath had ruptured intra-arterially, in the left iliac artery, at a radiopaque marker during the implantation of a prosthesis.The piece of catheter was recovered, by a lasso catheter.The patient was being treated for a ¿posea¿ 60mm aneurysm stent of the sub renal abdominal aorta.Prior to the procedure an angioplasty had been performed level of the common iliac artery and the left external iliac.The initial assembly planned bi-iliac aorta had to be converted to right iliac aorta stent associated with crossover interfemoral bypass, lengthening the intervention by one hour and thirty minutes.On awakening, the patient presented two arrests cardio-respiratory then a failure dynamic leading to death, which can be related to the significant increase in the duration of intervention.An image review of the first picture showed the distal portion of a pigtail catheter with markerbands, which appear offset/out of position.The other end of the catheter shows signs of a separation.The second picture showed the pigtail catheter with cordis written on the hub.The catheter is separated into two pieces and markerbands appear offset/ out of position.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18088834 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 5f 65cm 8sh pig tail super torque mb angiographic catheter which had been mounted on non-cordis guidewire and a 14f non-cordis introducer sheath had ruptured intra-arterially, in the left iliac artery, at a radiopaque marker during the implantation of a prosthesis.Approximately 1/3 from the distal end the device separated.The piece of catheter was recovered, by a lasso catheter.Before the operation on (b)(6) 2022 an angioscan of the aorta and lower limbs was performed.The scan was performed without any complication, especially allergic, and confirms the evolution of the aneurysm, which was measured at 60 mm, with a partial atherothrombus.We have axes that are very tortuous in the external iliac, as well as in the common iliac, a small left common iliac ectasia, on the right a good permeability of the common iliac stent, and especially a proximal neck.The patient was being treated for a ¿posea¿ 60mm aneurysm stent of the sub renal abdominal aorta.Prior to the procedure an angioplasty had been performed level of the common iliac artery and the left external iliac.The initial assembly planned bi-iliac aorta had to be converted to right iliac aorta stent associated with crossover interfemoral bypass, lengthening the intervention by one hour and thirty minutes.On awakening, the patient presented two arrests cardio-respiratory then a failure dynamic leading to death, which can be related to the significant increase in the duration of intervention.There were no discrepancies noted upon removal from the package nor prior to insertion of the product into the patient.The device was not inserted through a stopcock instead of a hemostasis valve.The device did not bend in the separation area.There was no resistance encountered when advancing the device nor when advancing the device on the guidewire.There was severe vessel tortuosity.There was no angulation of the vessel.The percentage of stenosis was 60% while the vessel was dilated before device mounting.The device was not used for chronic total occlusion (total occlusion > 3 months).Excessive torquing was not required.An image review of the first picture showed the distal portion of a pigtail catheter with markerbands, which appear offset/out of position.The other end of the catheter shows signs of a separation.The second picture showed the pigtail catheter with cordis written on the hub.The catheter is separated into two pieces and markerbands appear offset/ out of position.The device will be returned for evaluation.

Manufacturer Narrative

This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, b7, g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, a 5f 65cm 8sh pig tail super torque mb angiographic catheter which had been mounted on non-cordis guidewire and a 14f non-cordis introducer sheath had ruptured intra-arterially, in the left iliac artery, at a radiopaque marker during the implantation of a prosthesis.Approximately 1/3 from the distal end, the device separated.The piece of catheter was recovered, by a lasso catheter.Before the operation on an angioscan of the aorta and lower limbs was performed.The scan was performed without any complication, especially allergic, and confirms the evolution of the aneurysm, which was measured at 60 mm, with a partial atherothrombus.We have axes that are very tortuous in the external iliac, as well as in the common iliac, a small left common iliac ectasia, on the right a good permeability of the common iliac stent, and especially a proximal neck.The patient was being treated for a ¿posea¿ 60mm aneurysm stent of the sub renal abdominal aorta.Prior to the procedure an angioplasty had been performed level of the common iliac artery and the left external iliac.The initial assembly planned bi-iliac aorta had to be converted to right iliac aorta stent associated with crossover interfemoral bypass, lengthening the intervention by one hour and thirty minutes.On awakening, the patient presented two arrests cardio-respiratory then a failure dynamic leading to death, which can be related to the significant increase in the duration of intervention.There were no discrepancies noted upon removal from the package nor prior to insertion of the product into the patient.The device was not inserted through a stopcock instead of a hemostasis valve.The device did not bend in the separation area.There was no resistance encountered when advancing the device nor when advancing the device on the guidewire.There was severe vessel tortuosity.There was no angulation of the vessel.The percentage of stenosis was 60% while the vessel was dilated before device mounting.The device was not used for chronic total occlusion (total occlusion > 3 months).Excessive torquing was not required.Additional information provided indicated that the catheter was blocked on the non-cordis guidewire and was unable to be advance over the non-cordis guidewire.The device was returned for evaluation.Per visual analysis of the images provided the catheter (cath mb 5f pig 65cm 8sh) was observed inside a plastic bag and separated in two (2) parts.In addition, the marker bands were noted offset/out of position.Per visual analysis of the received device, the marker bands on the device were observed moved/out of position, the unit presented fourteen (14) out of the twenty marker bands moved/out of position, were noted approximately at 10.0 cm ,11.2 cm, 12.2 cm, 13.2 cm, 14.2 cm, 15.2 cm, 16.2 cm, 17.2 cm, 18.2 cm, 19.4 cm, 20.4 cm 21.5 cm, 22.5 cm and 23.5 cm to the distal section of the unit.Additionally, a separated condition was noted approximately at 25.0 cm from distal tip.No other anomalies were observed during the analysis.Per dimensional analysis the correct catheter outer diameter (od) and inner diameter (id) measurements were taken near the affected areas from the distal tip and were found within specification.A functional analysis could not be performed due the separated condition of the unit as received.Per microscopic analysis, amplified image of the moved marker bands and the separated condition was observed in the vision system.No other anomalies were observed during the microscopic examination.Due the separated condition found during the product evaluation, a sem analysis was performed, and results showed the separated area of the body/shaft of the cath mb 5f pig 65cm 8sh unit presented evidence of elongations on the separated area of the unit.The elongations found on the body/shaft material 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.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 18088834 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft)- resistance/friction - inner lumen¿ was not confirmed due to the conditions the unit was returned.The reported "catheter (body/shaft)-burst"/ "catheter (body/shaft) separated - in-patient¿ and "marker band (supertorque)-offset/out of position - in-patient were confirmed according to the pictures received, and analysis of the returned device.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.It was reported initial assembly planned bi-iliac aorta had to be converted to right iliac aorta stent associated with crossover interfemoral bypass, lengthening the intervention by one hour and thirty minutes.Since the retained portion of the catheter was removed with a lasso, it¿s difficult to state the additional time was related to its removal and was most likely the need to convert to bypass.Conversion to open surgical repair during an attempt at percutaneous intervention is a known and well understood occurrence associated with these interventional procedures.It was also reported that upon awakening after surgery the patient presented two arrests cardio-respiratory then a failure dynamic leading to death.With the limited information provided it is not possible to determine an exact cause for the event.Given the advanced age of the patient there are possible underlying patient specific and undisclosed comorbidities that may have contributed to the reported event.Catheter separation failures are commonly associated with elongations 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.It was also indicated that the catheter was blocked on the non-cordis guidewire and was unable to be advance over the non-cordis guidewire.Procedural factors such as proper flushing of the device, 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, the device analysis 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, a 5f 65cm 8sh pig tail super torque mb angiographic catheter which had been mounted on non-cordis guidewire and a 14f non-cordis introducer sheath had ruptured intra-arterially, in the left iliac artery, at a radiopaque marker during the implantation of a prosthesis.The catheter was blocked on the non-cordis guidewire and was unable to be advance over the non-cordis guidewire.Approximately 1/3 from the distal end the device separated.The piece of catheter was recovered, by a lasso catheter.The catheter broke at the marker.Before the operation on (b)(6) 2022 an angioscan of the aorta and lower limbs was performed.The scan was performed without any complication, especially allergic, and confirms the evolution of the aneurysm, which was measured at 60 mm, with a partial atherothrombus.We have axes that are very tortuous in the external iliac, as well as in the common iliac, a small left common iliac ectasia, on the right a good permeability of the common iliac stent, and especially a proximal neck that seemed quite favorable for an endoluminal treatment by stent.The patient was being treated for a 60mm aneurysm stent of the sub renal abdominal aorta.Prior to the procedure an angioplasty had been performed level of the common iliac artery and the left external iliac.The initial assembly planned bi-iliac aorta had to be converted to right iliac aorta stent associated with crossover interfemoral bypass, lengthening the intervention by one hour and thirty minutes.On awakening, the patient presented two arrests cardio-respiratory then a failure dynamic leading to death, which can be related to the significant increase in the duration of intervention.There were no discrepancies noted upon removal from the package nor prior to insertion of the product into the patient.The device was not inserted through a stopcock instead of a hemostasis valve.The device did not bend in the separation area.There was no resistance encountered when advancing the device nor when advancing the device on the guidewire.There was severe vessel tortuosity.There was no angulation of the vessel.The percentage of stenosis was 60% while the vessel was dilated before device mounting.The device was not used for chronic total occlusion (total occlusion > 3 months).Excessive torquing was not required.An image review of the first picture showed the distal portion of a pigtail catheter with markerbands, which appear offset/out of position.The other end of the catheter shows signs of a separation.The second picture showed the pigtail catheter with cordis written on the hub.The catheter is separated into two pieces and markerbands appear offset/ out of position.The device will be returned for evaluation.

• Brand Name: CATH MB 5F PIG 65CM 8SH
• 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: 15840407
• MDR Text Key: 304079358
• Report Number: 9616099-2022-06118
• Device Sequence Number: 1
• Product Code: DQO
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 532598C
• Device Catalogue Number: 532598C
• Device Lot Number: 18088834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2022
• 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: GUIDE AMPLATZ MEDTRONIC.; MEDTRONIC 14FR INTRODUCER ((B)(6)).; MEDTRONIC 14FR INTRODUCER.; UNKNOWN GUIDEWIRE.
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 115 KG