MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER 4MM20CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number: (b)(6).Please note that the device was returned but the engineering report is pending.Additional information received will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the filling and deflating speed of the balloon of a 4mm x 20cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was significantly slower.There was no reported patient injury.The percentage of stenosis was 80%.The contrast to saline ration was 1:1.The maximum inflation pressure was 10atm.It took 2 minutes to inflate the balloon and 2 minutes to deflate.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional b5 narrative: the access site was the femoral artery.The intended procedure was superficial femoral artery pta+ stent implantation.The target lesion was the superficial femoral artery.The calcified lesion was more than 80% occluded with no vessel tortuosity.It was considered a chronic total occlusion (cto).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 1:1.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, no difficulty crossing the lesion and the catheter was not ever in an acute bend.The plunger depressed into the syringe/indeflator when trying to inflate.The user was able to depress the plunger into the syringe/indeflator when trying to inflate.There was no leakage noted from the balloon, shaft, hub, or unknown segment.The maximum inflation pressure was 10atm.It took about 2 mins to inflate the balloon and about 2 minutes to deflate the balloon.The balloon was eventually deflated by negative pressure and was removed smoothly from the arterial sheath.The procedure was completed successfully by changing to another same model balloon.Procedural films are not available.Please note update to the udi# in section d4.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.D11 concomitant products: contrast media: iopamidol, bracco.Indeflator: merit.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the filling and deflating speed of the balloon of a 4mm x 20cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was significantly slower.There was no reported patient injury.The access site was the femoral artery.The intended procedure was superficial femoral artery pta+ stent implantation.The target lesion was the superficial femoral artery.The calcified lesion was more than 80% occluded with no vessel tortuosity.It was considered a chronic total occlusion (cto).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 prepped normally.The contrast to saline ratio was 1:1.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, no difficulty crossing the lesion and the catheter was not ever in an acute bend.The plunger depressed into the syringe/indeflator when trying to inflate.The user was able to depress the plunger into the syringe/indeflator when trying to inflate.There was no leakage noted from the balloon, shaft, hub, or unknown segment.The maximum inflation pressure was 10atm.It took about two mins to inflate the balloon and about two minutes to deflate the balloon.The balloon was eventually deflated by negative pressure and was removed smoothly from the arterial sheath.The procedure was completed successfully by changing to another same model balloon.Procedural films are not available.The product was returned for analysis.One non-sterile saber 4mm x 20cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a clear plastic bag.Per visual analysis, the balloon profile was inspected, and dried blood residues, as well as dried contrast solution was observed inside the balloon of the unit.No other anomalies could be seen.Per functional analysis, balloon inflation testing was intended to be performed; a lab sample inflator/deflator device filled with water was attached to the inflation lumen and positive pressure was intended to be applied to the unit; however, the balloon could not be inflated.Several inflation attempts were exhausted without success.Therefore, 24 hours of soaking the unit into a peroxide based disinfectant solution was performed along with an ultrasonic bath with the intent to cleanse the unit; however, the unit could not be cleansed by these means.Thus, it was decided to cross section the body shaft of the unit near the balloon area and probe a wire into the inflation lumen.Dried contrast solution was observed obstructing the passage.Therefore, the unit was dissected beyond the inflation lumen blockage and another cleansing attempt was applied to the unit on this section.This time the unit was successfully cleaned.Then, the balloon was once more tested for inflation and deflation.Inflation was successfully performed.Inflation time took approximately five seconds, and the deflation time took approximately three seconds to be achieved.No anomalies were observed.A product history record (phr) review of lot 82206138 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon inflation difficulty - partial or slow¿ and ¿balloon deflation difficulty - partial or slow¿ were not confirmed during device analysis.The exact causes cannot be determined.The device was received with dried blood residues, as well as dried contrast solution inside the balloon.Functional analysis was performed successfully once the device was properly cleansed and cross-sectioned.The device inflated/deflated without any difficulties or extended timeframe.It is likely procedural factors and handling of the device may have contributed to the events reported.Therefore, based on the information available, it is difficult to draw a clinical conclusion between the device and the events reported.According to the safety information of 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.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.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.Always verify integrity of the catheter after removal.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Apply negative pressures to the balloon for about 30 - 85 seconds until the balloon is deflated.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.¿ 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 4MM20CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer (Section G): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12638834
• Report Number: 9616099-2021-04930
• Device Sequence Number: 3452049
• Product Code: LIT
• UDI-Device Identifier: 20705032069493
• UDI-Public: 20705032069493
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 11/17/2021

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: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 48004020X
• Device Lot Number: 82206138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 10/15/2021; 11/12/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 10/20/2021; 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2020
• 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
• Patient Sex: Unknown