MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER 3MM30CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During an interventional procedure the body of a 3mm x 30cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter leaked inside the patient.The procedure was completed successfully by changing to another balloon.There was no reported patient injury.The target lesion was a 78% occluded lesion in the lower limb with some vessel tortuosity.The access site was the superficial femoral artery.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 and no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon did not inflate normally.The maximum inflation pressure was 15atm.The device was not returned for evaluation.A product history record (phr) review of lot 82205691 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft leakage - in-patient¿ was not confirmed as the device was not returned for analysis.The exact cause cannot be determined.Vessel characteristics of a 78% occlusion with vessel tortuosity may have contributed to the reported event.An occluded vessel makes crossing into the lesion difficult; it is likely damage to the body shaft material occurred in the attempt to cross.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 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
During an interventional procedure the body of a 3mm x 30cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter leaked inside the patient.The procedure was completed successfully by changing to another balloon.There was no reported patient injury.The target lesion was a 78% occluded lesion in the lower limb with some vessel tortuosity.The access site was the superficial femoral artery.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 and no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon did not inflate normally.The maximum inflation pressure was 15atm.The device will not be returned for evaluation.

• Brand Name: SABER 3MM30CM 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
• MDR Report Key: 11684821
• Report Number: 9616099-2021-04430
• Device Sequence Number: 3095832
• Product Code: LIT
• UDI-Device Identifier: 20705032069134
• UDI-Public: 20705032069134
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 48003030X
• Device Lot Number: 82205691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 75