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

Catalog Number	48002025X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the patient was in the endocrinology department with a diabetic foot, having balloon dilatation was proposed.Surgical dilatation was performed using 2mm 25cm saber; however, the balloon was found to be ruptured and the contrast agent oozed out.The balloon was replaced and dilatation was performed without any abnormality in the patient.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.
Additional Manufacturer Narrative
As reported, the patient was in the endocrinology department with a diabetic foot, having balloon dilatation was proposed.Surgical dilatation was performed using 2mm x 25cm saber percutaneous transluminal angioplasty (pta) dilatation catheter; however, the balloon was found to be ruptured and the contrast agent oozed out.The balloon was replaced, and dilatation was performed without any abnormality in the patient.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.The product was not returned for analysis.A product history record (phr) review of lot 82293786 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon- burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown, and procedural factors likely contributed to the reported event, as damage to balloon material may have occurred during crossing or upon inflation.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the 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.
Event or Problem Description
As reported, the patient was in the endocrinology department with a diabetic foot, having balloon dilatation was proposed.Surgical dilatation was performed using 2mm 25cm saber; however, the balloon was found to be ruptured and the contrast agent oozed out.The balloon was replaced and dilatation was performed without any abnormality in the patient.There was no reported injury to the patient.Additional information was requested; however, the information was not obtained after multiple attempts.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, d9, g3, g6, h1, h2, h3, and h11.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 Manufacturer Narrative
As reported, the patient was in the endocrinology department with a diabetic foot, having balloon dilatation was proposed.Surgical dilatation was performed using 2mm x 25cm saber percutaneous transluminal angioplasty (pta) dilatation catheter; however, the balloon was found to be ruptured and the contrast agent oozed out.The balloon was replaced, and dilatation was performed without any abnormality in the patient.There was no reported injury to the patient.Additional was requested; however, was not obtained after multiple attempts made.The product was returned for analysis.A non-sterile ¿saber 2mm25cm 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 that neither the balloon nor the shaft or luer hub present any damages or anomalies.The ballon was received deflated.No other outstanding details were noticed.Functional testing was performed using an inflator/deflator device attached to the inflation port.Positive pressure was applied with the purpose of reaching the rated burst pressure.During this test, a leak was observed in the body of the balloon.However, balloon inflation was not possible as the balloon presents a leakage located approximately 3.5cm from the distal tip.Sem analysis was not performed as the damages associated with the pin hole are visible with the magnification obtained with a vision system.The external surface of the balloon presented evidence of secondary scratch marks near the pin hole borders.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 probably led to the damaged condition found on the received device.It appears that the external surface near the pin hole border area was affected with a sharp object from the outside of the device.A product history record (phr) review of lot 82293786 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon- burst¿ was confirmed during device analysis as a pin hole was noted on the external surface of the balloon material.However, the exact cause could not be determined.Vessel characteristics, although unknown, and procedural factors likely contributed to the reported event, as damage to balloon material likely occurred during crossing or upon inflation as evidenced by device analysis.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.
Event or Problem Description
As reported, the patient was in the endocrinology department with a diabetic foot, having balloon dilatation was proposed.Surgical dilatation was performed using 2mm 25cm saber; however, the balloon was found to be ruptured and the contrast agent oozed out.The balloon was replaced, and dilatation was performed without any abnormality in the patient.There was no reported injury to the patient.Additional information was requested; however, the information was not obtained after multiple attempts.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: 18634349
• Report Number: 3007635982-2024-00017
• Device Sequence Number: 18083253
• Product Code: LIT
• UDI-Device Identifier: 20705032069226
• UDI-Public: (01)20705032069226(17)260930(10)82293786
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 06/10/2024

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 48002025X
• Device Lot Number: 82293786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/29/2024; 06/03/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 04/24/2024; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2023
• 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: 18 GUIDE WIRE.; BALLOON.; CONTRAST GUIDE WIRE.; CONTRAST TUBE.; SHORT SHEATH.
• Patient Sex: Unknown