MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM30CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48006030X

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

This report is related to report #9616099-2022-05653.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the three saber 6mm 30cm balloons busted in the superficial femoral artery (sfa) when being inflated to recommended inflation parameters.All three devices were removed intact in one piece from the patient.The case was completed with the use of a fourth saber 6mmx30cm 150.There was no reported injury to the patient.The products were stored properly according to the instructions for use (ifu).There was difficulty noted removing the products from the hoop.There was no difficulty removing the protective balloon covers, stylets, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting any of the devices into the patient.All three devices were prepped per the ifu and were able to maintain negative pressure.The lesion was in the superficial femoral artery.The lesion had moderate calcification with little vessel tortuosity.It was a chronic total occlusion (cto) to be treated.The balloons did not rupture while in a stent.The non-cordis inflation device was filled with 50/50 saline/contrast ratio.The inflation device was used successfully with other devices during the case.There was no resistance/friction while inserting the balloons through the rotating hemostatic valve or while inserting them through the guide catheter.The three balloons advanced through the vessel without difficulty.The balloons had slight difficulty while crossing the lesion.The catheters were never in an acute bend and were never kinked while being used.The devices will be returned for evaluation.

Manufacturer Narrative

This report is related to report # 9616099-2022-05653.As reported, the three saber 6mm x 30cm balloons busted in the superficial femoral artery (sfa) when being inflated to recommended inflation parameters.All three devices were removed intact (in one piece) from the patient.The case was completed with the use of a fourth saber 6mmx30cm 150.There was no reported injury to the patient.The products were stored properly according to the instructions for use (ifu).There was difficulty noted removing the products from the hoop.There was no difficulty removing the protective balloon covers, stylets, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting any of the devices into the patient.All three devices were prepped per the ifu and were able to maintain negative pressure.The lesion was in the superficial femoral artery.The lesion had moderate calcification with little vessel tortuosity.It was a chronic total occlusion (cto) to be treated.The balloons did not rupture while in a stent.The non-cordis inflation device was filled with 50/50 saline/contrast ratio.The inflation device was used successfully with other devices during the case.There was no resistance/friction while inserting the balloons through the rotating hemostatic valve or while inserting them through the guide catheter.The three balloons advanced through the vessel without difficulty.The balloons had slight difficulty while crossing the lesion.The catheters were never in an acute bend and were never kinked while being used.A non-sterile saber 6mm x 30cm 150 percutaneous transluminal angioplasty (pta) was received for analysis inside a plastic bag.Per visual analysis, a rupture on the balloon of the unit was observed.No other anomalies found.Per microscopic analysis, sem revealed the balloon of the saber presented evidence of scratch marks near the damaged area.This type of damage is commonly caused during the interaction of the 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 could probably led to the damaged condition found on the received device.It seems the material near the damage was ruptured with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82239678 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¿ were confirmed via device analysis as a leakage was noted during functional analysis for all three devices.However, the exact cause cannot be determined.A rupture was noted on the balloon material for all three devices.The outer surfaces of the balloon material presented evidence of scratch marks adjacent to the ruptures noted.It is likely vessel characteristics of moderate calcification and a chronic total occlusion likely contributed to the reported events as evidenced by device analysis.The balloon material near the ruptures, 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 safety information in the instructions for use, ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least (b)(4) of the balloons (with a (b)(4) confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ 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.

Event Description

As reported, the three saber 6mm 30cm balloons busted in the superficial femoral artery (sfa) when being inflated to recommended inflation parameters.All three devices were removed intact (in one piece) from the patient.The case was completed with the use of a fourth saber 6mmx30cm 150.There was no reported injury to the patient.The products were stored properly according to the instructions for use (ifu).There was difficulty noted removing the products from the hoop.There was no difficulty removing the protective balloon covers, stylets, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting any of the devices into the patient.All three devices were prepped per the ifu and were able to maintain negative pressure.The lesion was in the superficial femoral artery.The lesion had moderate calcification with little vessel tortuosity.It was a chronic total occlusion (cto) to be treated.The balloons did not rupture while in a stent.The non-cordis inflation device was filled with 50/50 saline/contrast ratio.The inflation device was used successfully with other devices during the case.There was no resistance/friction while inserting the balloons through the rotating hemostatic valve or while inserting them through the guide catheter.The three balloons advanced through the vessel without difficulty.The balloons had slight difficulty while crossing the lesion.The catheters were never in an acute bend and were never kinked while being used.The devices will be returned for evaluation.

Manufacturer Narrative

This report is related to report # 9616099-2022-05653.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the three saber 6mm 30cm balloons busted in the superficial femoral artery (sfa) when being inflated to recommended inflation parameters.All three devices were removed intact (in one piece) from the patient.The case was completed with the use of a fourth saber 6mmx30cm 150.There was no reported injury to the patient.The products were stored properly according to the instructions for use (ifu).There was difficulty noted removing the products from the hoop.There was no difficulty removing the protective balloon covers, stylets, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting any of the devices into the patient.All three devices were prepped per the ifu and were able to maintain negative pressure.The lesion was in the superficial femoral artery.The lesion had moderate calcification with little vessel tortuosity.It was a chronic total occlusion (cto) to be treated.The balloons did not rupture while in a stent.The non-cordis inflation device was filled with 50/50 saline/contrast ratio.The inflation device was used successfully with other devices during the case.There was no resistance/friction while inserting the balloons through the rotating hemostatic valve or while inserting them through the guide catheter.The three balloons advanced through the vessel without difficulty.The balloons had slight difficulty while crossing the lesion.The catheters were never in an acute bend and were never kinked while being used.The devices will be returned for evaluation.

• Brand Name: SABER 6MM30CM 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: 14465601
• MDR Text Key: 292608215
• Report Number: 9616099-2022-05654
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032068182
• UDI-Public: (01)20705032068182(17)241231(10)82239678
• 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,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48006030X
• Device Catalogue Number: 48006030X
• Device Lot Number: 82239678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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: BOSTON SCIENTIFIC ENCORE-INFLATION DEVICE; BOSTON SCIENTIFIC ENCORE-INFLATION DEVICE