MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM6CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48006006X

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

As reported, the balloon of a saber 6mm 6cm 150 burst below nominal pressure while in the vessel.There was no reported injury to the patient.The balloon ruptured 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.The balloon was filled with 1/3 omnipaque contrast and 2/3 heparinized saline.The inflation device was used successfully with other devices.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 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.This device is available for analysis but has not yet been received.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82207219 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 6mm 6cm 150 burst below nominal pressure while in the vessel.There was no reported injury to the patient.The balloon ruptured 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.The balloon was filled with 1/3 omnipaque contrast and 2/3 heparinized saline.The inflation device was used successfully with other devices.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 case was completed with the use of another unknown balloon.The device will be returned for evaluation.

Event Description

As reported, the balloon of a saber 6mm-6cm 150 burst below nominal pressure while in the vessel.There was no reported injury to the patient.The balloon ruptured 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.The balloon was filled with 1/3 omnipaque contrast and 2/3 heparinized saline.The inflation device was used successfully with other devices.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 case was completed with the use of another unknown balloon.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the balloon of a saber 6mm 6cm 150 burst below nominal pressure while in the vessel.There was no reported injury to the patient.The balloon ruptured 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.The balloon was filled with 1/3 omnipaque contrast and 2/3 heparinized saline.The inflation device was used successfully with other devices.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 case was completed with the use of another unknown balloon.The product was returned for analysis.A non-sterile saber 6mm x 6cm 150 percutaneous transluminal angioplasty (pta) was received for analysis inside a plastic bag.Per visual analysis, a rupture in the balloon distal area was observed.No other anomalies could be found.Per functional testing, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and pressure was applied.A balloon leakage was observed at a rupture in the distal section of the balloon.No other anomalies were observed.Per microscopic analysis, sem analysis was performed, results showed that the balloon leakage was caused by a rupture on the distal section of the balloon surface.The external surface of the balloon presented evidence of micro-tears and 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.Likely, the same factors that caused the observed micro-tears and scratch marks on the balloon outer surface could have led to the ruptured condition found on the received balloon.The internal surface of the balloon did not present evidence of damages on the surrounding areas of the rupture.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 found during the sem analysis.A product history record (phr) review of lot 82207219 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 as a leakage was noted on the proximal section of the balloon surface due to a puncture/rupture.However, the exact cause cannot be determined.The outer surface of the balloon presented evidence of micro-tears and scratch marks adjacent to the balloon rupture.The device ruptured intra-stent, stent struts can easily damage balloon material when attempting to cross inside the stent or upon inflation.It is likely these procedural factors and characteristics within the stent contributed to the reported events as evidenced by device analysis.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 6MM6CM 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: 14190929
• MDR Text Key: 290095275
• Report Number: 9616099-2022-05579
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069592
• UDI-Public: (01)20705032069592(17)231031(10)82207219
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 48006006X
• Device Catalogue Number: 48006006X
• Device Lot Number: 82207219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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