MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV SABER 7MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: smart stent contrast: iopamironi.Telephone number is : (b)(6).During post-dilatation of a lesion in the iliac artery with 90% stenosis, a 7x4cm saber rx percutaneous transluminal angioplasty (pta) balloon catheter ruptured at eight atmospheres during its initial inflation.It was replaced with another saber rx of the same size which was inflated without any problems.The procedure was completed.There was no reported patient injury.The lesion was a little calcified with a little calcification.The procedure being performed was an endovascular iliac treatment case.The access site was the left femoral.Initially, the lesion was pre-dilated with a 6x4cm saber pta balloon catheter and a smart stent was implanted.There was no difficulty removing the complaint balloon from the forming tube.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped normally.The contrast to saline ratio was 50:50.The same indeflator was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and or while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion.The catheter was never in an acute bend.The maximum inflation pressure was eight atm.The balloon catheter did not kink while being used.It was easily removed from the vessel and from the other devices.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82202901 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of calcification likely contributed to the reported event, as calcification is known to damage balloon material.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and reported event.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of 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.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
During post-dilatation of a lesion in the iliac artery with 90% stenosis, a 7x4cm saber rx percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 8 atmospheres during its initial inflation.It was replaced with another saber rx of the same size which was inflated without any problems.The procedure was completed.There was no reported patient injury.The lesion was a little calcified with a little calcification.The procedure being performed was an endovascular iliac treatment case.The access site was the left femoral.Initially, the lesion was pre-dilated with a 6x4cm saber pta balloon catheter and a smart stent was implanted.There was no difficulty removing the complaint balloon from the forming tube.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.The contrast to saline ratio was 50:50.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion.The catheter was never in an acute bend.The maximum inflation pressure was 8 atm.The balloon catheter did not kink while being used.It was easily removed from the vessel and from the other devices.Patient demographic information and the reason for the procedure were requested but was not provided by the physician.The device will not be returned for analysis because it was discarded by the hospital.

• Brand Name: SABER 7MM4CM 90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• MDR Report Key: 12699125
• Report Number: 9616099-2021-05008
• Device Sequence Number: 17070485
• Product Code: LIT
• UDI-Device Identifier: 20705032068847
• UDI-Public: (01)20705032068847(17)230831(10)82202901
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 48007004S
• Device Lot Number: 82202901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1