MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO POWERFLEXPRO 6MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned but the engineering report is pending.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 6mm x 4cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) was advanced over the wire (unknown) into the patient; however, when inflation was attempted, the balloon wouldn't inflate.When the balloon was taken out, it appeared that there was a small hole in the balloon and the balloon leaked out contrast.Another cordis balloon was used to complete the procedure and the outcome was good.There was no reported patient injury.The operator was a trained powerflex pro user.The device is expected to be returned for analysis.A peripheral angiography was being performed.There was no difficulty removing the product from the forming tube.No kinks or other damages noted prior to inserting the product the product into the patient.The device appeared to prep normally.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.The lesion was slightly calcified with no vessel tortuosity.The lesion was not a chronic total occlusion (total occlusion >3 months).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.Additional patient and procedural details were requested but were unknown.

Manufacturer Narrative

As reported, the 6mm x 4cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) was advanced over the wire (unknown) into the patient; however, when inflation was attempted, the balloon wouldn¿t inflate.When the balloon was taken out, it appeared that there was a small hole in the balloon and the balloon leaked out contrast.Another cordis balloon was used to complete the procedure and the outcome was good.There was no reported patient injury.The operator was a trained powerflex pro user.A peripheral angiography was being performed.There was no difficulty removing the product from the forming tube.No kinks or other damages noted prior to inserting the product into the patient.The device appeared to prep normally.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.The lesion was slightly calcified with no vessel tortuosity.The lesion was not a chronic total occlusion (total occlusion >3 months).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.Additional patient and procedural details were requested but were unknown.The product was returned for analysis.A non-sterile powerflex pro 6mm x 4cm 80 was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The balloon was received without being inflated.The unit was thoroughly inspected, and no damages or anomalies were observed.Functional test was performed, an inflator/deflator device was attached to the inflation port.Balloon inflation test was done by applying positive pressure using an inflator/deflator device; however, the balloon did not inflate as expected due to a leakage condition observed at the shaft located near the proximal area of the balloon.Sem results showed the torn area of the body/shaft of the powerflex pro 6 mm 4 cm 80 unit presented evidence of scratch marks along the torn area on the body/shaft material.This type of damage is commonly caused during the interaction of the body/shaft material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the body/shaft probably led to the torn condition found on the received device.It seems the body/shaft material near the rupture was torn either due to the interaction of the unit with calcified spicules located on the lesion or with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82205448 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 - unable to inflate¿ was confirmed during device analysis as a leakage was noted from the shaft of the device impeding the balloon¿s ability to inflate.The reported ¿balloon leakage¿ was not confirmed as the leakage originated from the shaft of the device.The exact cause cannot be determined.The body shaft material near the rupture, appears to have been torn either due to the interaction of the shaft with calcified spicules located on the lesion or with a sharp object from the outside of the catheter.It is likely procedural factors and vessel characteristics contributed to the events reported as evidenced by device analysis.According to the safety information in the instructions for use, ¿prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.If resistance is met during manipulation, determine the cause of the resistance before proceeding.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.¿ 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: POWERFLEXPRO 6MM4CM 80
• Type of Device: 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: 12301647
• MDR Text Key: 265839777
• Report Number: 9616099-2021-04771
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059517
• UDI-Public: (01)20705032059517(17)230930(10)82205446
• Combination Product (y/n): N
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 4400604S
• Device Lot Number: 82205448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN WIRE.; UNKNOWN WIRE.