MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX4MM20CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51004020L

Device Problem Burst Container or Vessel (1074)

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

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

A saber 4mm x 20cm x 155cm rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion and inflated; however, it ruptured after its nominal pressure at about 10-14 atmospheres (atm).The balloon was inflated once before it ruptured.It was unknown whether it was calcification of the lesion or the quality of the saber rx.Therefore, the saber rx was replaced with a new same sized balloon catheter (non-cordis) and the procedure was continued.The device was opened in sterile field.The lesion was the right superficial femoral artery.The lesion was severely calcified, moderately tortuous and 95 percent stenosed.The device was not used for a chronic total occlusion.The device was stored and handled as per the instructions for use (ifu).There was no damage noted to the packaging of the device.There was no difficulty removing the product from the hoop, protective balloon cover, stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally (i.E.Maintain negative pressure).A non-cordis indeflator was used.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, nor while inserting the balloon through the guide catheter.An approach was made from the left inguinal to the right side with a guiding sheath (6f, non-cordis).An unknown guidewire (0.014) crossed the stenosis part.The saber rx was used for pre-pta.No unusual force was used at any time during the procedure.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 82186283 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿balloon~ burst - at/below rbp¿ could not be confirmed and the exact root cause could not be determined.Handling and procedural factors such as vessel characteristics( severely calcified, moderately tortuous and 95 percent stenosed lesion) may have contributed to the reported event as the presence of calcification is known to cause damage to balloons.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 review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, the 4mm x 20cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion and inflated; however, it ruptured after its nominal pressure at about 10-14 atmospheres (atm).The balloon was inflated once before it ruptured.It was unknown whether it was calcification of the lesion or the quality of the saber rx.Therefore, the saber rx was replaced with a new same sized balloon catheter (non-cordis) and the procedure was continued.There was no reported patient injury.The device was opened in sterile field.The lesion was the right superficial femoral artery.The lesion was severely calcified, moderately tortuous and 95 percent stenosed.The device was not used for a chronic total occlusion.The device was stored and handled as per the instructions for use (ifu).There was no damage noted to the packaging of the device.There was no difficulty removing the product from the hoop, protective balloon cover, stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally (i.E.Maintain negative pressure).A non cordis indeflator was used.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, nor while inserting the balloon through the guide catheter.An approach was made from the left inguinal to the right side with a guiding sheath (6f, non-cordis).An unknown guidewire (0.014) crossed the stenosis part.The saber rx was used for pre-pta.No unusual force was used at any time during the procedure.Additional procedural details were requested but are unknown.The saber rx will not be returned for analysis as it was discarded in the hospital.

• Brand Name: SABER RX4MM20CM155
• Type of Device: CATHETER, 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 Key: 11068854
• MDR Text Key: 224521629
• Report Number: 9616099-2020-04151
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 51004020L
• Device Catalogue Number: 51004020L
• Device Lot Number: 82186283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2020
• Date Device Manufactured: 02/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1