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 02/14/2022

Event Type  malfunction  

Event Description

As reported, the balloons of two saber 7mm 10cm burst when attempting to inflate inside a placed stent (unknown).The case was completed with the use of a powerflex pro 7x100mm balloon.There was no reported injury to the patient.The balloons were noted to have burst below the rated burst pressure (rbp).The products were stored properly according to the instructions for use (ifu).There was no difficulty removing the device from the hoop, removing the protective balloon cover, and/or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device was prepped per the ifu and was prepped normally.The balloon was able to hold and maintain negative pressure.The intended lesion was in the superficial femoral artery that was noted to have a calcification.Atherectomy was used prior, then stented.The devices were not being used to treat a chronic total occlusion (cto).The vessel was noted to have no tortuosity.The inflation device was filled with ¼ contrast to ¾ saline.The same inflation device was used successfully with other devices during procedure.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting through the guide catheter.Both devices advanced through the vessel without difficulty.The devices crossed the lesion without difficulty.The catheters were never in an acute bend or were ever kinked while being used.Both devices were removed intact (in one piece) form the patient.It was noted that the two balloons burst in the same stent that the 3rd balloon was successful in.Both devices 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 the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the balloons of two saber 7mm 10cm burst when attempting to inflate inside a placed stent (unknown).The case was completed with the use of a powerflex pro 7x100mm balloon.There was no reported injury to the patient.The balloons were noted to have burst below the rated burst pressure (rbp).The products were stored properly according to the instructions for use (ifu).There was no difficulty removing the device from the hoop, removing the protective balloon cover, and/or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device was prepped per the ifu and was prepped normally.The balloon was able to hold and maintain negative pressure.The intended lesion was in the superficial femoral artery that was noted to have a calcification.Atherectomy was used prior, then stented.The devices were not being used to treat a chronic total occlusion (cto).The vessel was noted to have no tortuosity.The inflation device was filled with ¼ contrast to ¾ saline.The same inflation device was used successfully with other devices during procedure.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting through the guide catheter.Both devices advanced through the vessel without difficulty.The devices crossed the lesion without difficulty.The catheters were never in an acute bend or were ever kinked while being used.Both devices were removed intact (in one piece) form the patient.It was noted that the two balloons burst in the same stent that the 3rd balloon was successful in.Both devices will be returned for evaluation.

Manufacturer Narrative

As reported, the balloons of two saber 7mm 10cm burst when attempting to inflate inside a placed stent (unknown).The case was completed with the use of a powerflex pro 7 x 100mm balloon.There was no reported injury to the patient.The balloons were noted to have burst below the rated burst pressure (rbp).The products were stored properly according to the instructions for use (ifu).There was no difficulty removing the device from the hoop, removing the protective balloon cover, and/or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device was prepped per the ifu and was prepped normally.The balloon was able to hold and maintain negative pressure.The intended lesion was in the superficial femoral artery that was noted to have calcification.Atherectomy was used prior, then stented.The devices were not being used to treat a chronic total occlusion (cto).The vessel was noted to have no tortuosity.The inflation device was filled with ¼ contrast to ¾ saline.The same inflation device was used successfully with other devices during the procedure.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting through the guide catheter.Both devices advanced through the vessel without difficulty.The devices crossed the lesion without difficulty.The catheters were never in an acute bend or were ever kinked while being used.Both devices were removed intact (in one piece) form the patient.It was noted that the two balloons burst in the same stent that the 3rd balloon was successful in.The device was returned for analysis.Two non-sterile saber 7mm x 10cm 150 percutaneous transluminal angioplasty (pta) units were received for analysis inside a plastic bag.The two non-sterile saber units were randomly numbered/identified as unit one, and unit two to perform the analysis.The unit identified as unit number one was analyzed under this complaint (b)(4).Per visual analysis of unit number one, no damages could be observed by the naked eye.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 coming from a rupture in the middle area of the balloon.No other anomalies were observed.Per microscopic analysis, the unit was inspected under the vision system and balloon rupture was confirmed on the middle section of the balloon.Sem analysis was performed to identify the possible root cause of the balloon rupture, results showed the leakage/ripped balloon of the saber presented evidence of scratch marks near the damaged area on the balloon.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 probably led to the damaged condition found on the received device.It seems the material near the damage was ripped 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 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 analysis for both complaint devices.A leakage was confirmed through functional analysis for both returned devices.The first balloon presented evidence of a rupture/ripped condition on the middle area of the balloon while the second balloon was noted to have a rupture on the distal section of the balloon surface.The outer surface of both balloons presented evidence of scratch marks adjacent to the balloon ruptures.The balloon material near the rupture, appears to have been torn due to the interaction of the balloon with a sharp object from the outside of the balloon.The devices were used for post-dilation of an implanted stent.Stent struts can easily damage balloon material when attempting to cross inside the stent and/or upon inflation.Therefore, based on the information available for review, it is likely vessel characteristics, procedural factors and handling of the devices together 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 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: 13723901
• MDR Text Key: 287193902
• Report Number: 9616099-2022-05437
• 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: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 02/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• 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: POWERFLEX PRO 7X100 BALLOON CATH; UNK STENT