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U.S. Department of Health and Human Services

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

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CORDIS CASHEL SABER RX6MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
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.
 
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Brand NameSABER RX6MM4CM155
Type of DeviceCATHETER, 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 Key9447952
MDR Text Key199106791
Report Number9616099-2019-03394
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51006004L
Device Catalogue Number51006004L
Device Lot Number82171037
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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