MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER RX6MM15CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problem Difficult to Remove (1528)

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

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Telephone: (b)(6).The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.Please note that the device in this report is not sold in the u.S., however, it is similar to other pta balloon catheters sold by cordis with the lit pro code.

Event Description

After the percutaneous transluminal angioplasty (pta), the doctor felt resistance when trying to retrieve the 6mm x 15cm 155 saber rapid exchange (rx) pta balloon catheter in the unknown guiding sheath.The physician pulled the saber rx out of the body and checked the balloon, its shaft had stretched.Therefore, it was replaced with an unknown balloon catheter and the procedure was completed.There was no reported patient injury.This was an endovascular therapy (evt) case.The lesion was the superficial femoral artery and a contralateral approach was made using a non-cordis guiding catheter.The saber rx was used for preparation for a drug coated balloon (dcb) angioplasty.The device will not be returned as it was discarded due to infectious disease.

Manufacturer Narrative

After the percutaneous transluminal angioplasty (pta), the doctor felt resistance when trying to retrieve the 6mm x 15cm 155 saber rapid exchange (rx) pta balloon catheter in the unknown guiding sheath.The physician pulled the saber rx out of the body and checked the balloon, its shaft had stretched.Therefore, it was replaced with an unknown balloon catheter and the procedure was completed.There was no reported patient injury.This was an endovascular therapy (evt) case.The lesion was the superficial femoral artery, and a contralateral approach was made using a non-cordis guiding catheter.The saber rx was used for preparation for a drug coated balloon (dcb) angioplasty.The device was not returned for analysis as it was discarded due to infectious disease.A product history record (phr) review of lot 82182425 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft unraveled stretched - in-patient¿ and ¿balloon withdrawal difficulty - through guide/sheath¿ could not be confirmed as the device was not returned for analysis.The exact cause cannot be determined.It is likely vessel characteristics, procedural factors and handling of the catheter may have contributed to the events reported by the customer.The balloon may have been induced to a tensile force that exceeded the material yield strength resulting in the stretching of the shaft.However, without return of the device for analysis it is difficult to draw a clinical conclusion between the device and the reported events.According to the safety information of 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.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 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 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 RX6MM15CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11088419
• MDR Text Key: 224521377
• Report Number: 9616099-2020-04159
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 51006015L
• Device Lot Number: 82182425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1