MAUDE Adverse Event Report: CORDIS US. CORP SABER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	48003025X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported, the 3mm 25cm saber percutaneous transluminal angioplasty (pta) was used for dilatation.However, the balloon ruptured below rated burst pressure (rbp), and extravasation of contrast medium occurred.The product was removed intact from the patient.The procedure was completed by switching to another balloon, specifically a balloon, sheath, and a pressure plunge device.There was no reported injury to the patient.There was an arterial occlusion of the lower limbs.The product was stored correctly as per the instructions for use (ifu).There were no difficulties removing it from the hoop, the protective balloon cover, or any of the sterile packaging components.No kinks or damages were observed prior to insertion into the patient.The device was prepared according to the ifu and was prepped normally.The procedure was intended to treat a stenotic lesion, which was calcified.The vessel tortuosity was mild, and the stenosis was at 90%.There was no resistance or friction noted when inserting the balloon through the rotating hemostatic valve or the guide catheter.There was no difficulty advancing the balloon catheter through the vessel or while crossing the lesion.The catheter was not in any acute bends or kinks during use.The contrast to saline ratio used was 1:1.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the 3mm 25cm saber percutaneous transluminal angioplasty (pta) was used for dilatation.However, the balloon ruptured below rated burst pressure (rbp), and extravasation of contrast medium occurred.The product was removed intact from the patient.The procedure was completed by switching to another balloon, specifically a balloon, sheath, and a pressure plunge device.There was no reported injury to the patient.There was an arterial occlusion of the lower limbs.The product was stored correctly as per the instructions for use (ifu).There were no difficulties removing it from the hoop, the protective balloon cover, or any of the sterile packaging components.No kinks or damages were observed prior to insertion into the patient.The device was prepared according to the ifu and was prepped normally.The procedure was intended to treat a stenotic lesion, which was calcified.The vessel tortuosity was mild, and the stenosis was at 90%.There was no resistance or friction noted when inserting the balloon through the rotating hemostatic valve or the guide catheter.There was no difficulty advancing the balloon catheter through the vessel or while crossing the lesion.The catheter was not in any acute bends or kinks during use.The contrast to saline ratio used was 1:1.The device was returned for analysis.A non-sterile ¿saber 3mm25cm 150¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed on a metallic tray to be inspected.A thorough inspection was performed on the unit observing no damages.The ballon was received deflated.No other outstanding details were noticed.Functional testing was performed, an inflator/deflator device was attached to the inflation port.Balloon inflation was done by applying positive pressure with the purpose of reaching the rated burst pressure.However, complete inflation to rbp was not possible due to a leakage condition on the shaft located approximately 26cm from the distal tip.The area where the leaking is located was inspected with a vision system observing a puncture on the surface of the shaft and secondary scratch marks located near the damaged border 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 surface could have led to the damaged condition found on the received device as it appears the damaged area was affected with a sharp object from the outside of the device.The reported ¿balloon burst at/below rbp¿ was not confirmed during functional analysis as no anomalies were noted to the balloon material and the balloon inflated with no difficulties.However, subsequent findings of ¿body/shaft leakage¿ was confirmed as a leakage was noted coming from the shaft of the device.However, the exact cause could not be determined.Device analysis revealed the body/shaft was torn and a leakage was noted from the damaged area upon functional analysis.The outer surface of the shaft presented evidence of scratch marks near the damaged area.Based on the information provided it appears the body/shaft leakage was caused by the interaction of the shaft material with a sharp object.Vessel characteristics of calcification and stenosis and procedural factors likely contributed to the reported event as calcification can damage the body/shaft material during use.According to the instructions for use, which are not intended to mitigate risk, ¿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.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.¿ the information available does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Additional Manufacturer Narrative
As reported, the 3mm 25cm saber percutaneous transluminal angioplasty (pta) was used for dilatation.However, the balloon ruptured below rated burst pressure (rbp), and extravasation of contrast medium occurred.The product was removed intact from the patient.The procedure was completed by switching to another balloon, specifically a balloon, sheath, and a pressure plunge device.There was no reported injury to the patient.There was an arterial occlusion of the lower limbs.The product was stored correctly as per the instructions for use (ifu).There were no difficulties removing it from the hoop, the protective balloon cover, or any of the sterile packaging components.No kinks or damages were observed prior to insertion into the patient.The device was prepared according to the ifu and was prepped normally.The procedure was intended to treat a stenotic lesion, which was calcified.The vessel tortuosity was mild, and the stenosis was at 90%.There was no resistance or friction noted when inserting the balloon through the rotating hemostatic valve or the guide catheter.There was no difficulty advancing the balloon catheter through the vessel or while crossing the lesion.The catheter was not in any acute bends or kinks during use.The contrast to saline ratio used was 1:1.The device was returned for analysis.A non-sterile ¿saber 3mm25cm 150¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed on a metallic tray to be inspected.A thorough inspection was performed on the unit observing no damages.The ballon was received deflated.No other outstanding details were noticed.Functional testing was performed, an inflator/deflator device was attached to the inflation port.Balloon inflation was done by applying positive pressure with the purpose of reaching the rated burst pressure.However, complete inflation to rbp was not possible due to a leakage condition on the shaft located approximately 26cm from the distal tip.The area where the leaking is located was inspected with a vision system observing a puncture on the surface of the shaft and secondary scratch marks located near the damaged border 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 surface could have led to the damaged condition found on the received device as it appears the damaged area was affected with a sharp object from the outside of the device.The reported ¿balloon burst at/below rbp¿ was not confirmed during functional analysis as no anomalies were noted to the balloon material and the balloon inflated with no difficulties.However, subsequent findings of ¿body/shaft leakage¿ was confirmed as a leakage was noted coming from the shaft of the device.However, the exact cause could not be determined.Device analysis revealed the body/shaft was torn and a leakage was noted from the damaged area upon functional analysis.The outer surface of the shaft presented evidence of scratch marks near the damaged area.Based on the information provided it appears the body/shaft leakage was caused by the interaction of the shaft material with a sharp object.Vessel characteristics of calcification and stenosis and procedural factors likely contributed to the reported event as calcification can damage the body/shaft material during use.According to the instructions for use, which are not intended to mitigate risk, ¿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.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.¿ 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 or Problem Description
As reported, the 3mm 25cm saber percutaneous transluminal angioplasty (pta) was used for dilatation.However, the balloon ruptured below rated burst pressure (rbp), and extravasation of contrast medium occurred.The product was removed intact from the patient.The procedure was completed by switching to another balloon, specifically a balloon, sheath, and a pressure plunge device.There was no reported injury to the patient.There was an arterial occlusion of the lower limbs.The product was stored correctly as per the instructions for use (ifu).There were no difficulties removing it from the hoop, the protective balloon cover, or any of the sterile packaging components.No kinks or damages were observed prior to insertion into the patient.The device was prepared according to the ifu and was prepped normally.The procedure was intended to treat a stenotic lesion, which was calcified.The vessel tortuosity was mild, and the stenosis was at 90%.There was no resistance or friction noted when inserting the balloon through the rotating hemostatic valve or the guide catheter.There was no difficulty advancing the balloon catheter through the vessel or while crossing the lesion.The catheter was not in any acute bends or kinks during use.The contrast to saline ratio used was 1:1.The device will be returned for evaluation.

• Brand Name: SABER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 20279213
• Report Number: 3007635982-2024-00233
• Device Sequence Number: 7415054
• Product Code: LIT
• UDI-Device Identifier: 20705032069127
• UDI-Public: (01)20705032069127(17)270430(10)82309666
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2024

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
• Device Catalogue Number: 48003025X
• Device Lot Number: 82309666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/16/2024; Not provided
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/22/2024; 10/23/2024
• Date Device Manufactured: 05/02/2024
• 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: N/A.
• Patient Age: 72 YR
• Patient Sex: Male