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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION SABER RX8MM2CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51008002L
Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, an 8mm x 2cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter could not cross the lesion. It was then removed from the patient¿s body, and it was confirmed that the distal end of the tip was frayed. There was no reported patient injury. Prior to that, an unknown wire crossed the lesion. The procedure was an endovascular therapy case (evt) of the superficial femoral artery (sfa). The sfa had mild calcification, mild angulation, and mild tortuosity. There was 90% stenosis, and it was not a cto. The device was not resterilized. The device was stored and prepped as per the instructions for use (ifu). There were no anomalies noted when removed from the package nor during prep. The balloon did become caught in the lesion but there was no resistance met while withdrawing the device from the vessel. The balloon was not caught in a deployed stent. The procedure was completed using another unknown device. Other procedural details were requested but are unknown, unavailable, or not applicable. The device was not returned for evaluation as it was discarded in the hospital. A product history record (phr) review of lot 82182742 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported by the customer as ¿distal tip frayed/split/torn - in-patient¿ and ¿pta/ptca system failure to cross¿ could not be confirmed as the device was not returned for analysis. The exact cause cannot be determined. The lesion had mild calcification, mild angulation, and mild tortuosity with 90% stenosis which may have contributed to the frayed tip and difficulty crossing reported by the customer. It is likely vessel characteristics, procedural factors and handling of the catheter contributed to the events reported by the customer. Difficulty crossing a lesion, or an anatomical structure is a known procedural occurrence. Difficulty crossing a lesion has been investigated, and the consequences of crossing difficulty occurring during clinical use of the device are usually addressed by modification in technique or substitution with another device. Crossing difficulty is most commonly related to patient anatomy, operator technique and appropriate device selection. Therefore, based on the information available and without the return of the product for analysis, it is difficult to draw a clinical conclusion between the device and the reported events. According to 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. 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 review nor the product analysis suggests that the found damages could be related to the manufacturing process of the unit. Therefore, no corrective or preventive actions will be taken at this time.
 
Event Description
As reported, an 8mm x 2cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter could not cross the lesion. It was then removed from the patient¿s body, and it was confirmed that the distal end of the tip was frayed. There was no reported patient injury. Prior that, an unknown wire crossed the lesion. The procedure was an endovascular therapy case (evt) of the superficial femoral artery (sfa). The sfa had mild calcification, mild angulation, and mild tortuosity. There was 90% stenosis and it was not a cto. The device was not resterilized. The device was stored and prepped as per the instructions for use (ifu). There were no anomalies noted when removed from the package nor during prep. The balloon did become caught in the lesion but there was no resistance met while withdrawing the device from the vessel. The balloon was not caught in a deployed stent. The procedure was completed using another unknown device. Other procedural details were requested but are unknown, unavailable, or not applicable. The device will not be returned for evaluation as it was discarded in the hospital.
 
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Brand NameSABER RX8MM2CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key12768455
MDR Text Key281761225
Report Number9616099-2021-05041
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51008002L
Device Catalogue Number51008002L
Device Lot Number82182742
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/08/2021 Patient Sequence Number: 1
Treatment
UNKNOWN WIRE, UNKNOWN DEVICE
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