CORDIS CORPORATION POWERFLEXPRO 10MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number N/A |
Device Problems
Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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A review of the manufacturing documentation associated with lot 82189366 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
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Event Description
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As reported, the middle part of an unknown stent was inflated with 10mm x 4cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc), however, it ruptured at 12 atmospheric pressure (atm).The physician attempted to remove the powerflex pro but it got stuck on the distal end of the unknown sheath and the balloon shaft got separated.The separated distal end of the powerflex pro was on the non-cordis guidewire; there was a separation of the body/shaft of the catheter.Another unknown sheath (7fr) was inserted from the middle of the brachial vein.The guidewire was grasped with a non-cordis snare and withdrawn into the sheath, which was a pull-through condition.The guidewire, the fragments, and the sheath were removed together from the patient.The distal end of the tip of powerflex pro was removed with the guidewire.All of the balloon parts were removed and the procedure completed.The patient had to be punctured with an additional unknown sheath in one place.Other than that, there is no patient injury.The patient is stable.This was a vascular access intervention therapy (vaivt) case.The target lesion had no calcification, mild tortuosity, mild angulation, 90% stenosis, and was not a cto.Initially, an unknown sheath was inserted from the brachial vein.Pta was performed for restenosis in the unknown stent.Plain old balloon angioplasty (poba) was performed with a non-cordis balloon catheter (8mm) after a non-cordis guidewire crossed the lesion.No issues were confirmed with the powerflex pro before and during use for patient.The doctor commented that the lesion was restenosis in the stent, so the powerflex pro may have hit the strut and became a rupture.The device was not resterilized.There were no anomalies noted when removed from the package or during prep.There was no difficulty removing the product from the hoop, removing the protective balloon cover, or removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.An unknown indeflator was used and it was used successfully with other devices.The plunger depressed into the syringe/indeflator when trying to inflate.The user was unable to depress the plunger into the syringe/indeflator when trying to inflate.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.The device was not inserted through a stopcock.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon inflated normally.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for analysis.The separated tip will also be returned for analysis.
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Manufacturer Narrative
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Complaint conclusion: the middle part of an unknown stent was inflated with 10mm x 4cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc), however, it ruptured at 12 atmospheric pressure (atm).The physician attempted to remove the powerflex pro but it got stuck on the distal end of the unknown sheath and the balloon shaft got separated.The separated distal end of the powerflex pro was on the non-cordis guidewire; there was a separation of the body/shaft of the catheter.Another unknown sheath (7fr) was inserted from the middle of the brachial vein.The guidewire was grasped with a non-cordis snare and withdrawn into the sheath, which was a pull-through condition.The guidewire, the fragments, and the sheath were removed together from the patient.The distal end of the tip of powerflex pro was removed with the guidewire.All of the balloon parts were removed and the procedure completed.The patient had to be punctured with an additional unknown sheath in one place.Other than that, there is no patient injury.The patient is stable.This was a vascular access intervention therapy (vaivt) case.The target lesion had no calcification, mild tortuosity, mild angulation, 90% stenosis, and was not a cto.Initially, an unknown sheath was inserted from the brachial vein.Pta was performed for restenosis in the unknown stent.Plain old balloon angioplasty (poba) was performed with a non-cordis balloon catheter (8mm) after a non-cordis guidewire crossed the lesion.No issues were confirmed with the powerflex pro before and during use for patient.The doctor commented that the lesion was restenosis in the stent, so the powerflex pro may have hit the strut and became a rupture.The device was not resterilized.There were no anomalies noted when removed from the package or during prep.There was no difficulty removing the product from the hoop, removing the protective balloon cover, or removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.An unknown indeflator was used and it was used successfully with other devices.The plunger depressed into the syringe / indeflator when trying to inflate.The user was unable to depress the plunger into the syringe/indeflator when trying to inflate.There was no resistance / friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.The device was not inserted through a stopcock.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon inflated normally.Other procedural details were requested but are unknown, unavailable, or not applicable.The product was returned for analysis.A non-sterile unit of a powerflex pro 10mm x 4cm 80cm balloon catheter was received for analysis coiled inside a plastic bag.An unknown 7f catheter sheath introducer and an unknown guidewire were received along with the device.Per visual analysis, the balloon was observed burst and separated on the balloon¿s middle area.Blood residues were observed inside the balloon.No other anomalies were observed.Per sem analysis the balloon burst and separation were caused by a rupture on the balloon surface.The inner surface presented no anomalies adjacent to the balloon rupture.The outer surface presented evidence of scratch marks and tears adjacent to the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and tears on the balloon outer surface likely led to the rupture condition found on the device.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot: 82189366 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body / shaft - separated - in-patient¿ was not confirmed since the body / shaft of the unit was observed intact, not separated.The reported ¿balloon burst-at / below rbp¿ and "balloon - separated - in-patient" were confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (a rate of stenosis of 90%) and procedural factors (in-stent restenosis) may have contributed to the event as evidenced by abrasions noted on the outer surface during analysis.Sem analysis results showed that the balloon burst and separation were caused by a rupture on the balloon surface.The balloon material presented evidence of scratch marks and tears adjacent to the balloon rupture.This type of damages is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and tears on the balloon outer surface likely led to the rupture condition found on the received balloon.It is suggested that the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.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 review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective / preventive action will be taken at this time.
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