CORDIS CORPORATION POWERFLEX P3 F5 7X10 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 4207000S |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Complaint conclusion: the balloon of a 7mm x 10cm 80cm powerflex p3 f5 percutaneous transluminal angioplasty (pta) balloon catheter ruptured before reaching its nominal pressure.As a result, a new 7mm x 10cm 80cm powerflex p3 balloon catheter was used in place of the 7mm x 10cm 80cm powerflex p3 pta balloon catheter and was used without issue.This was during a procedure to treat a fistula lesion which had an 80% stenosis but showed no signs of chronic total occlusion (cto), calcification, or tortuosity.There was no reported injury to the patient.A non-cordis.035 guidewire was used for the procedure without issue.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction during insertion of the device.The device was able to track toward the lesion and cross the lesion without difficulty.The device was never put into an acute bend and did not kink during its use.After the rupture occurred, the device was able to be removed easily and remained in one piece during its removal.The product was not returned for analysis.A product history record (phr) review of lot 82227787 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.Procedural factors or lesion characteristics may have contributed to the reported event.According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.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.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.¿ neither the phr review nor the information provided 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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Event Description
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As reported, the balloon of a 7mm x 10cm 80cm powerflex p3 f5 percutaneous transluminal angioplasty (pta) balloon catheter ruptured before reaching its nominal pressure.As a result, a new 7mm x 10cm 80cm powerflex p3 balloon catheter was used in place of the 7mm x 10cm 80cm powerflex p3 pta balloon catheter and was used without issue.There was no reported injury to the patient.This was during a procedure to treat a fistula lesion which had an 80% stenosis but showed no signs of chronic total occlusion (cto), calcification, or tortuosity.A non-cordis.035 guidewire was used for the procedure without issue.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction during insertion of the device.The device was able to track toward the lesion and cross the lesion without difficulty.The device was never put into an acute bend and did not kink during its use.After the rupture occurred, the device was able to be removed easily and remained in one piece during its removal.The device was discarded and will not be returned.
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