MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM25CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48005025X

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/30/2022

Event Type  malfunction  

Event Description

As reported, the balloon of a saber 5mm25cm 150 ruptured below burst pressure while in the vessel.There was no reported injury to the patient.The balloon was noted to rupture below rbp while in the vessel.The balloon did not rupture while in a stent.The product was stored properly according to the instruction for use (ifu).The was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or damages noted prior to inserting into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The intended procedure was to treat the superficial femoral artery.The lesion was noted to be calcified.The vessel did not have any tortuosity.The device was not being used to treat a chronic total occlusion.There was no resistance/friction while inserting the device through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The catheter advanced through the vessel without difficulty.The device crossed the lesion without difficulty.The catheter was never in an acute bend and was never kinked.The device was removed intact (in one piece) from the patient.The inflation device was used successfully with other devices.The balloon was being filled with 1/3 omnipaque and 2/3 heparinized saline.The case was completed with the use of another unknown balloon.The device will be returned for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a saber 5mm25cm 150 ruptured below burst pressure while in the vessel.There was no reported injury to the patient.The balloon was noted to rupture below rbp while in the vessel.The balloon did not rupture while in a stent.The product was stored properly according to the instruction for use (ifu).The was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or damages noted prior to inserting into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The intended procedure was to treat the superficial femoral artery.The lesion was noted to be calcified.The vessel did not have any tortuosity.The device was not being used to treat a chronic total occlusion.There was no resistance/friction while inserting the device through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The catheter advanced through the vessel without difficulty.The device crossed the lesion without difficulty.The catheter was never in an acute bend and was never kinked.The device was removed intact (in one piece) from the patient.The inflation device was used successfully with other devices.The balloon was being filled with 1/3 omnipaque and 2/3 heparinized saline.The case was completed with the use of another unknown balloon.The device will not be returned for evaluation after further clarification.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: as reported, the balloon of a saber 5mm x 25cm 150 ruptured below burst pressure while in the vessel.There was no reported injury to the patient.The balloon was noted to rupture below rbp while in the vessel.The balloon did not rupture while in a stent.The product was stored properly according to the instruction for use (ifu).The was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or damages noted prior to inserting into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The intended procedure was to treat the superficial femoral artery.The lesion was noted to be calcified.The vessel did not have any tortuosity.The device was not being used to treat a chronic total occlusion.There was no resistance/friction while inserting the device through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The catheter advanced through the vessel without difficulty.The device crossed the lesion without difficulty.The catheter was never in an acute bend and was never kinked.The device was removed intact (in one piece) from the patient.The inflation device was used successfully with other devices.The balloon was being filled with 1/3 omnipaque and 2/3 heparinized saline.The case was completed with the use of another unknown balloon.The product was not returned for analysis.A product history record (phr) review of lot 82219391 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 calcification likely contributed to the reported event, as calcification is known to damage balloon material.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.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82219391 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a saber 5mm25cm 150 ruptured below burst pressure while in the vessel.There was no reported injury to the patient.The balloon was noted to rupture below rbp while in the vessel.The balloon did not rupture while in a stent.The product was stored properly according to the instruction for use (ifu).The was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or damages noted prior to inserting into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The intended procedure was to treat the superficial femoral artery.The lesion was noted to be calcified.The vessel did not have any tortuosity.The device was not being used to treat a chronic total occlusion.There was no resistance/friction while inserting the device through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The catheter advanced through the vessel without difficulty.The device crossed the lesion without difficulty.The catheter was never in an acute bend and was never kinked.The device was removed intact (in one piece) from the patient.The inflation device was used successfully with other devices.The balloon was being filled with 1/3 omnipaque and 2/3 heparinized saline.The case was completed with the use of another unknown balloon.The device will be returned for evaluation.

• Brand Name: SABER 5MM25CM 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: 14191020
• MDR Text Key: 289975354
• Report Number: 9616099-2022-05581
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069561
• UDI-Public: (01)20705032069561(17)240331(10)82219391
• 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: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 48005025X
• Device Catalogue Number: 48005025X
• Device Lot Number: 82219391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Date Device Manufactured: 04/22/2021
• 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: MERIT INFLATION DEVICE.; UNK BALLOON.