MAUDE Adverse Event Report: CORDIS CASHEL SABER 4MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48004004S

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: after an unknown guidewire crossed the lesion, a 4mm x 4cm 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at eight atmospheres (atm) after it was inserted for pre-dilation.There was no reported patient injury.This was an endovascular therapy (evt) case.The lesion was the external iliac artery with chronic total occlusion (cto).There was severe calcification of lesion but there was no vessel tortuosity.The device was stored, handled and prepped per the instructions for use (ifu).The product was of normal appearance when it was removed from its packaging.There were no kinks or other damages noted prior to inserting the product into the patient.The device did prep normally (i.E.Maintain negative pressure).A non-cordis inflation device was used.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The device did not have to pass through a previously placed stent.The balloon inflated normally but ruptured during its initial inflation.The catheter was never in an acute bend.Some force was applied when it crossed the lesion, but it was not excessive.The product was removed intact (in one piece) from the patient.There were no other anomalies noted when the device was removed from the patient.The procedure was completed using a non-cordis balloon catheter of the same size.Other additional procedural details were requested but were unknown.The device was not returned for analysis as the device was discarded.A product history record (phr) review of lot 17624760 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, such as severe calcification with a chronic total occlusion, may have contributed to the reported event.It is known that calcium may damage balloon material.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.According to the warnings in the safety information in the instructions for use ¿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.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium.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 phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, an unknown guidewire crossed the lesion and, after that, a 4mm x 4cm 90 saber percutaneous transluminal angioplasty (pta) dilatation balloon catheter (bc) was inserted for pre-dilation.However, it ruptured at 8 atmospheres (atm).Therefore, it was replaced with a new non-cordis balloon catheter of the same size and the procedure was continued.There was no injury to the patient.This was an endovascular therapy (evt) case.The lesion was the external iliac artery with chronic total occlusion (cto).There was severe calcification of lesion but there was no vessel tortuosity.The device was stored, handled and prepped per the instructions for use (ifu).The product looked normal when it was removed from its packaging.There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The device did prep normally (i.E.Maintain negative pressure).A non-cordis inflation device was used (indeflator/syringe).The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The device did not have to pass through a previously placed stent.The balloon inflated normally.The balloon ruptured during its initial inflation.The catheter was never in an acute bend.Some force was applied when it crossed the lesion, but it was not excessive.The product was removed intact (in one piece) from the patient.There were no other anomalies noted when the device was removed from the patient.There was no injury to the patient.Other additional procedural details were requested but were unknown.The device will not be returned for analysis because it was discarded.

• Brand Name: SABER 4MM4CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9485101
• MDR Text Key: 199107721
• Report Number: 9616099-2019-03410
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069851
• UDI-Public: 20705032069851
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 48004004S
• Device Catalogue Number: 48004004S
• Device Lot Number: 17624760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2016
• 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