MAUDE Adverse Event Report: CORDIS US CORP. SABERX; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51004015L

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/01/2023

Event Type  malfunction  

Manufacturer Narrative

The product history record review is anticipated; however, it has not yet been finalized.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a 4mm x 15 cm saber percutaneous transluminal angioplasty (pta) balloon catheter was inflated but ruptured during initial inflation at 8 atmospheres (atm).The complaint device was replaced with another saber device of different size.There was no reported patient injury.The lesion was the superficial femoral artery.Vessel calcification and vessel tortuosity were mild with ninety percent stenosis.The device was not used for a chronic total occlusion.The device was stored, handled and prepped according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There was no difficulty removing the product from the hoop or removing the protective balloon cover nor difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The product was removed intact (in one piece) from the patient.The device will not be returned for evaluation.

Manufacturer Narrative

As reported, the balloon of a 4mm x 15cm saber percutaneous transluminal angioplasty (pta) balloon catheter was inflated but ruptured during initial inflation at eight atmospheres (atm).The complaint device was replaced with another saber device of different size.There was no reported patient injury.The lesion was the superficial femoral artery.Vessel calcification and vessel tortuosity were mild with ninety percent stenosis.The device was not used for a chronic total occlusion.The device was stored, handled, and prepped according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The product was removed intact (in one piece) from the patient.The device was not returned for evaluation.A product history record (phr) review of lot 82206175 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 of stenosis may have contributed to the reported event, as damage balloon material may have occurred during crossing or upon inflation.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and event reported.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: SABERX
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25; el coyol alajuela, costa rica ; 7863138372
• MDR Report Key: 16832984
• MDR Text Key: 314192592
• Report Number: 3007635982-2023-00165
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075913
• UDI-Public: (01)20705032075913(17)231130(10)82206175
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 51004015L
• Device Lot Number: 82206175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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
• Treatment: SABER