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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX8MM2CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX8MM2CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51008002L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2019
Event Type  malfunction  
Manufacturer Narrative
Complaint conclusion: a saber rx 8mm x 2cm 155cm percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion and inflated; however, it ruptured during nominal pressure. There was no reported patient injury. The target lesion was in the superficial femoral artery (sfa). The device was stored and handled per the instructions for use (ifu). There was not any difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. There were not any kinks or other damages noted prior to inserting the product into the patient. The same indeflator was used successfully with other devices. There was not any resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter. There was not any difficulty advancing the balloon catheter through the vessel. The product was removed intact from the patient. The product was not returned for analysis. A product history record (phr) review of lot 17610329 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, although unknown, may have contributed to the reported event as the presence of calcification is known to cause damage to balloon material. However, without the return of the product for analysis it is difficult to draw a clinical conclusion between the device and the reported event. 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 limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
 
Event Description
As reported, a saber rx 8mm x 2cm 155 percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion, inflated, however it ruptured during it¿s nominal pressure. There was no reported patient injury. The target lesion was in the superficial femoral artery (sfa). The device was stored and handled per the instructions for use (ifu). There was not any difficulty removing the product from the hoop. There was not any difficulty removing the product from the protective balloon cover. There was not any difficulty removing the stylet or any of the sterile packaging components. There were not any kinks or other damages noted prior to inserting the product into the patient. The same indeflator was used successfully with other devices. There was not any resistance/friction while inserting the balloon through the rotating hemostatic valve. There was not any resistance/friction while inserting the balloon through the guide catheter. There was not any difficulty advancing the balloon catheter through the vessel. The product was removed intact from the patient.
 
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Brand NameSABER RX8MM2CM155
Type of DeviceCATHETER, 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
7863138372
MDR Report Key8743659
MDR Text Key150854613
Report Number9616099-2019-03041
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
UNK
Number of Events Reported1
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 06/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model Number51008002L
Device Catalogue Number51008002L
Device Lot Number17610329
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/24/2016
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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