MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51005030L

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot (17655851) 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.(b)(4).

Event Description

As reported, the saber rx pta dilation catheter (5 mm 30 cm 155) was inflated as a pre dilation.However, when the physician attempted to remove the saber rx pta balloon catheter from the patient, there was resistance felt.After several attempts, the shaft separated at its guidewire exit port.A non-cordis snare catheter attempted retention of the separated balloon, but there was resistance felt.The separated balloon was removed by removing it with the sheath in the end.There was no reported patient injury.The target lesion was from the right common femoral artery to the common iliac artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was 100 % (cto).The left common femoral artery to the left common iliac artery has been treated before.This was a leriche syndrome treatment.There were no anomalies confirmed prior to/during use.Initially, approaches were made from the right brachial artery with a 6f 73 cm non-cordis guiding sheath and from the right popliteal artery with a 4f non-cordis long sheath.A 0.014 non-cordis guidewire crossed the lesion and the guidewire was exchanged to a new 0.014 non-cordis guidewire.Then, a saber pta balloon catheter was inflated as a pre dilatation, then the sheath that was inserted from the right popliteal artery was removed and the same balloon catheter made hemostasis.After this pre-dilatation, a non-cordis stent was inserted for stent implant, however it could not cross the lesion.As of note: ¿the physician commented that the catheter itself might not be well balanced because of the diameter of 5 mm which is relatively big and the length of 30 cm¿.The product will not be returned for analysis due to patient¿s infectious disease.

Manufacturer Narrative

After further review of additional information received the sections have been updated accordingly.A 5x300mm 155cm saber rx percutaneous transluminal angioplasty (pta) dilation catheter was inflated for pre-dilation; however, when the physician attempted to remove the saber rx pta balloon catheter from the patient, there was resistance felt.After several attempts, the shaft separated at its guidewire exit port.A non-cordis snare catheter attempted retention of the separated balloon, but there was resistance felt.The separated balloon was removed by removing it with the sheath in the end.There was no reported patient injury.The intended procedure was treatment of leriche syndrome, an aortoiliac occlusive disease.The target lesion was from the right common femoral artery to the common iliac artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was 100%, chronic total occlusion (cto).The left common femoral artery to the left common iliac artery had been treated before.There were no anomalies confirmed prior to/during use.Initially, approaches were made from the right brachial artery with a 6f 73cm non-cordis guiding sheath and from the right popliteal artery with a 4f non-cordis long sheath.A 0.014 non-cordis guidewire crossed the lesion and the guidewire was exchanged to a new 0.014 non-cordis guidewire.Then, a saber pta balloon catheter was inflated, then the sheath that was inserted from the right popliteal artery was removed and the same balloon catheter made hemostasis.After this pre-dilatation, a non-cordis stent was inserted for stent implant, however it could not cross the lesion.As of note: ¿the physician commented that the catheter itself might not be well balanced because of the diameter of 5mm which is relatively big and the length of 30 cm¿.The device was not returned for analysis due to the patient¿s infectious disease.A device history record (dhr) review of lot 17655851 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft separated in patient,¿ and ¿pta/ptca system withdrawal difficulty from vessel¿ could not be confirmed as the device was not returned for analysis.The exact cause of the withdrawal difficulty and separation could not be determined.Based on the limited information available for review, vessel characteristics (100% stenosis/cto) and handling/procedural factors may have contributed to the withdrawal difficulty and subsequent separation reported.According to the instructions for use, which is not intended as a mitigation, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of resistance before proceeding.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

After further review of additional information received the sections have been updated accordingly.Additional information received indicates that there were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package.The device was not resterilized.The device was not pulled from the packaging by the hub.The device was prepped according to instructions for use (ifu).There was no difficulty encountered flushing the balloon catheter.There was no difficulty encountered connecting the hub to the indeflator device.A non-cordis indeflator device was used in the procedure.The same indeflator was used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel.There was difficulty tracking the device through the vessel or lesion.There were kink/bent noted after device was removed from patient.There was no unusual force used at any time during the procedure.The complaint balloon was separated and the separated fragment(s) was removed from the patient.A percutaneous transluminal angioplasty (pta) was performed on the following day and the patient left the hospital.There was no patient injury.A 5x300mm 155cm saber rx percutaneous transluminal angioplasty (pta) dilation catheter was inflated for pre-dilation; however, when the physician attempted to remove the saber rx pta balloon catheter from the patient, there was resistance felt.After several attempts, the shaft separated at its guidewire exit port.A non-cordis snare catheter attempted retention of the separated balloon, but there was resistance felt.The separated balloon was removed by removing it with the sheath in the end.There was no reported patient injury.The intended procedure was treatment of leriche syndrome, an aortoiliac occlusive disease.The target lesion was from the right common femoral artery to the common iliac artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was 100%, chronic total occlusion (cto).The left common femoral artery to the left common iliac artery had been treated before.There were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package.The device was not resterilized.There were no anomalies confirmed prior to/during use.Initially, approaches were made from the right brachial artery with a 6f 73cm non-cordis guiding sheath and from the right popliteal artery with a 4f non-cordis long sheath.A 0.014 non-cordis guidewire crossed the lesion and the guidewire was exchanged to a new 0.014 non-cordis guidewire.Then, a saber pta balloon catheter was inflated, then the sheath that was inserted from the right popliteal artery was removed and the same balloon catheter made hemostasis.After this pre-dilatation, a non-cordis stent was inserted for stent implant, however it could not cross the lesion.The device was not pulled from the packaging by the hub.The device was prepped according to instructions for use (ifu).There was no difficulty encountered flushing the balloon catheter.There was no difficulty encountered connecting the hub to the indeflator device.A non-cordis indeflator device was used in the procedure.The same indeflator was used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel.There was difficulty tracking the device through the vessel or lesion.As of note: ¿the physician commented that the catheter itself might not be well balanced because of the diameter of 5mm which is relatively big and the length of 30 cm¿.There were kink/bent noted after device was removed from patient.There was no unusual force used at any time during the procedure.The complaint balloon was separated and the separated fragment(s) was removed from the patient.A percutaneous transluminal angioplasty (pta) was performed on the following day and the patient left the hospital.There was no patient injury.The device was not returned for analysis due to the patient¿s infectious disease.A device history record (dhr) review of lot 17655851 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft separated in patient,¿ and ¿pta/ptca system withdrawal difficulty from vessel¿ could not be confirmed as the device was not returned for analysis.The exact cause of the withdrawal difficulty and separation could not be determined.Based on the limited information available for review, vessel characteristics (100% stenosis/cto) and handling/procedural factors may have contributed to the withdrawal difficulty and subsequent separation reported.According to the instructions for use, which is not intended as a mitigation, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of resistance before proceeding.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SABER RX5MM30CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7155245
• MDR Text Key: 96067351
• Report Number: 9616099-2017-01746
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 51005030L
• Device Lot Number: 17655851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 02/14/2018; 03/12/2018
• Supplement Dates FDA Received: 02/16/2018; 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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: - GUIDEWIRE (0.014 AGURU, BOSTON SCIENTIFIC); - GUIDEWIRE (0.014 CRUISE, ASAHI INTECC); - LONG SHEATH (4F MEDIKIT); - STENT (6*150 INNOVA, BOSTON SCIENTIFIC)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention