MAUDE Adverse Event Report: CORDIS CORPORATION 5FR SABERX RADIANZ 5MM20CM 190; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	R51005020L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of a 5f 5mm x 20cm 190cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter ruptured around its nominal pressure during an inflation within a heavily calcified superficial femoral artery (sfa) lesion.As a result, a 5mm x 25cm 155cm saberx pta balloon catheter was used in place of the saberx radianz balloon catheter to continue the procedure.There was no reported injury to the patient.The sfa lesion had a 100% stenosed chronic total occlusion (cto), and there was no vessel tortuosity present.A 6f brite-tip radianz catheter sheath introducer (csi) was used without issue to access the left radial artery.The device was stored and prepped per the instructions for use (ifu).A 50/50 contrast and saline mixture was used to prep the device.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.The device was able to track towards and cross the lesion without difficulty.The device was never put into an acute bend, and it did not kink during its use.The balloon was close to its nominal pressure when it burst.The device was able to be removed easily and remained in one piece during its removal.The device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82237589 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.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g4, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, the balloon of a 5f 5mm x 20cm 190cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter ruptured around its nominal pressure during an inflation within a heavily calcified superficial femoral artery (sfa) lesion.As a result, a 5mm x 25cm 155cm saberx pta balloon catheter was used in place of the saberx radianz balloon catheter to continue the procedure.There was no reported injury to the patient.The sfa lesion had a 100% stenosed chronic total occlusion (cto), and there was no vessel tortuosity present.A 6f brite-tip radianz catheter sheath introducer (csi) was used without issue to access the left radial artery.The device was stored and prepped per the instructions for use (ifu).A 50/50 contrast and saline mixture was used to prep the device.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.The device was able to track towards and cross the lesion without difficulty.The device was never put into an acute bend, and it did not kink during its use.The balloon was close to its nominal pressure when it burst.The device was able to be removed easily and remained in one piece during its removal.The product was returned for analysis.One non-sterile 5f 5mm x 20cm 190cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a plastic bag.Per visual analysis, no anomalies were observed on the unit by the naked eye.Functional testing was performed on the unit, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and pressure was applied.However, a leakage was observed at a rupture in the proximal area of the balloon.No other anomalies were observed.Per microscopic analysis, sem was performed to identify the possible root cause of the balloon rupture.Results showed that the balloon of the 5fr saberx radianz 5mm20cm 190 device presented evidence of scratch marks near the rupture area.These types of damages are 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 these areas probably led to the damaged condition found on the received device.Additionally, there is evidence of fatigue striations near the rupture area, which are commonly associated with separation caused by material tensile overload.Therefore, it is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation/rupture.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82237589 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 during device analysis.However, the exact cause could not be determined.The proximal area of the balloon was noted to have a ruptured condition with scratch marks noted to the outer portion of the balloon material.Vessel characteristics of severe calcification with 100% stenosis likely contributed to the reported event based on the analysis findings.Calcification is known to damage balloon material; it is likely this occurred when attempting to cross the calcified stenosed lesion or upon inflation.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.

• Brand Name: 5FR SABERX RADIANZ 5MM20CM 190
• Common Device Name: 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: 15445543
• Report Number: 3007635982-2022-00005
• Device Sequence Number: 12690196
• Product Code: LIT
• UDI-Device Identifier: 20705032082003
• UDI-Public: (01)20705032082003(17)241231(10)82237589
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: R51005020L
• Device Catalogue Number: R51005020L
• Device Lot Number: 82237589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 10/23/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/21/2022; 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5MM X 25CM SABERX RADIANZ PTA BALLOON CATHETER; 6F BRITE-TIP RADIANZ CSI
• Patient Sex: Unknown