MAUDE Adverse Event Report: CORDIS CASHEL SABER RX6MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006004L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

A 6mm x 4cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 16 atmospheres post-dilation.There was no reported patient injury.The target lesion was left external iliac artery with a chronic total occlusion (cto).The lesion was moderately calcified and had 100% stenosis.There was severe vessel tortuosity.Therefore, it was replaced with a new non-cordis balloon catheter and the procedure was completed.A cross-over approach was made with a non-cordis sheath together with a non-cordis guidewire to cross the lesion.A saber balloon catheter (4mm) inflated the lesion and the 8x60 smart stent was implanted.The patient had no infectious disease.The device stored and handled per the instructions for use (ifu).There were no difficulties removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped as per the ifu and the device prepped normally.The contrast media used was a non-cordis product with a saline ratio of 1:1.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 guide catheter.The catheter was ever in an acute bend.There was no unusual force used at any time during the procedure.The product was removed intact (in one piece) from the patient.Additional procedural details were requested but are unknown.The device was not returned for evaluation as it was discarded.A product history record (phr) review of lot 82171037 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst- above rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.However, the device was inflated above the rbp indicated in the instructions for use, this along with vessel characteristics of moderate calcification and a chronic total occlusion may have contributed to the reported event.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 to inflate the balloon.¿ 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, a 6mm 4cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 16 atmosphere post-dilation.Therefore, it was replaced with a new non-cordis balloon catheter and the procedure was completed.There was no reported patient injury.A cross-over approach was made with a non-cordis sheath together with a non-cordis guidewire to cross the lesion.A saber balloon catheter (4mm) inflated the lesion and the 8x60 smart stent was implanted.The target lesion was left external iliac artery with chronic total occlusion (cto).The patient had no infectious disease.The device will not be returned for evaluation because it was discarded.The lesion was moderately calcified and had 100% stenosis.There was severe vessel tortuosity.The device stored and handled per the instructions for use (ifu).There were no difficulties removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped as per the ifu and the device prepped normally.The contrast media used was non-cordis product with saline ratio of 1:1.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 guide catheter.The catheter was ever in an acute bend.There was no unusual force used at any time during the procedure.The product was removed intact (in one piece) from the patient.Additional procedural details were requested but are unknown.

• Brand Name: SABER RX6MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cahir road 0000 ; EI 0000
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9447952
• MDR Text Key: 199106791
• Report Number: 9616099-2019-03394
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 51006004L
• Device Catalogue Number: 51006004L
• Device Lot Number: 82171037
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/10/2019
• Date Device Manufactured: 05/29/2019
• 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