MAUDE Adverse Event Report: CORDIS CORPORATION SABER 7MM10CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48007010X

Device Problem Burst Container or Vessel (1074)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

As reported, the balloon of a 7mm x 10cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured during inflation of a calcified peripheral lesion.The balloon catheter was removed easily from the patient, it remained in one piece during removal, and there was no reported injury to the patient.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components, and there were no kinks to the device noted prior to insertion.The device maintained negative pressure during preparation and the contrast used for the procedure was omnipaque 300.There was no difficulty experienced while the saber pta balloon catheter crossed the lesion and a mixture of 1/3 contrast and 2/3 saline was used to inflate the balloon to nominal pressure when it burst.Information on the completion of the procedure was requested but was not provided.The device will be returned for analysis.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82230545 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the balloon of a 7mm x 10cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured during inflation of a calcified peripheral lesion.The balloon catheter was removed easily from the patient, it remained in one piece during removal, and there was no reported injury to the patient.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components, and there were no kinks to the device noted prior to insertion.The device maintained negative pressure during preparation and the contrast used for the procedure was omnipaque 300.There was no difficulty experienced while the saber pta balloon catheter crossed the lesion and a mixture of 1/3 contrast, and 2/3 saline was used to inflate the balloon to nominal pressure when it burst.Information on the completion of the procedure was requested but was not provided.The product was returned for analysis.A non-sterile saber 7mm x 10cm 150 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon appears to have been previously inflated.No other anomalies were observed.Per functional analysis, balloon inflation was performed.A lab inflator/deflator device was attached to the inflation lumen of unit and pressure applied.A leakage of water was observed coming from the middle area of the balloon.Per sem analysis, results showed that the balloon leakage was caused by a rupture on the balloon surface.The inner surface presented no anomalies near the balloon rupture.The outer surface presented evidence of scratch marks near the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon outer surface could have led to the ruptured condition found on the received device.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82230545 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¿ was confirmed via device analysis.However, the exact cause cannot be determined.A leakage was confirmed during functional analysis as a rupture was noted on the balloon surface.The outer surface of the balloon presented evidence of scratch marks adjacent to the balloon rupture.It is likely vessel characteristics of calcification contributed to the reported event as evidenced by device analysis.The balloon material near the rupture, appears to have been torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.According to the warnings in the safety information in the instructions for use ¿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 7MM10CM 150
• 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: 13047414
• MDR Text Key: 285838510
• Report Number: 9616099-2021-05211
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069707
• UDI-Public: (01)20705032069707(17)240731(10)82230545
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 48007010X
• Device Catalogue Number: 48007010X
• Device Lot Number: 82230545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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: OMNIPAQUE 300.