MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM15CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005015L

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

When the 5mm x 15cm x 155cm saber rapid exchange (rx) balloon catheter (bc) was used for post-dilation of a non-cordis stent, it could not be inflated completely, so, the device was removed from the patient and was inflated at the outside of the body; however, at that time, unknown contrast media and saline in the balloon of a 5mm x 15cm x 155cm saber rapid exchange (rx) balloon catheter (bc) spouted from one place.They mentioned that it looked like a pinhole rupture.There was no reported patient injury.The lesion was the superficial femoral artery which had chronic total occlusion (cto).Saber was inflated at its nominal pressure in the stent.They commented that the situation was like a constriction.The doctor increased the pressure further, but the pressure did not increase.The device will be returned for analysis.

Manufacturer Narrative

When the 5mm x 15cm x 155cm saber rapid exchange (rx) balloon catheter (bc) was used for post-dilation of a non-cordis stent, it could not be inflated completely, so, the device was removed from the patient and was inflated at the outside of the body; however, at that time, unknown contrast media and saline in the balloon of a 5mm x 15cm x 155cm saber rapid exchange (rx) balloon catheter (bc) spouted from one place.They mentioned that it looked like a pinhole rupture.There was no reported patient injury.The lesion was the superficial femoral artery which had chronic total occlusion (cto).Saber was inflated at its nominal pressure in the stent.They commented that the situation was like a constriction.The doctor increased the pressure further, but the pressure did not increase.The device was not returned for analysis.The product was not returned for analysis as it was discarded due to infectious disease.A product history record (phr) review of lot 82191530 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage - during positive pressure¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.The device was used for a chronically occluded vessel post stent implantation, stent struts can easily damage balloon material if caution is not met when attempting to cross inside the stent and upon inflation.However, without 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 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.

• Brand Name: SABER RX5MM15CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10968929
• MDR Text Key: 222306720
• Report Number: 9616099-2020-04106
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 51005015L
• Device Catalogue Number: 51005015L
• Device Lot Number: 82191530
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN CONTRAST MEDIA; UNKNOWN SENT