As reported, the saber 3mm15cm 150 balloon expanded past the marker bands.There were no reported patient injuries.The device was received by the representative the same morning of the procedure.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There were no anomalies noted to the deice when it was taken out of the packaging.There was no difficulty removing the product from the packaging or removing the product from the hoop.There was no difficulty removing the protective balloon cover.The product was inspected prior to use and appeared to be normal.There were no kinks or other damages noted prior to inserting the product into the patient.There was no unusual force used at anytime during the procedure.The lesion was moderately calcified.There was no vessel tortuosity.The device was not used for a chronic total occlusion (cto).The balloon did not inflate normally.The maximum inflation pressure was nominal.All the marker bands were accounted for at the end of the procedure.The patient is doing fine.The target lesion was the anterior tibial.The device will not be returned for analysis.
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The saber 3mm x 15cm x 150cm balloon expanded past the marker bands.There was no reported patient injury.The target lesion was the anterior tibial.There were no kinks or other damages noted prior to inserting the product into the patient.There was no unusual force used at any time during the procedure.The lesion was moderately calcified.There was no vessel tortuosity.The device was not used for a chronic total occlusion (cto).The balloon did not inflate normally.The maximum inflation pressure was nominal.The device was received by the representative the same morning of the procedure.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There were no anomalies noted to the device when it was taken out of the packaging.There was no difficulty removing the product from the packaging or removing the product from the hoop.There was no difficulty removing the protective balloon cover.The product was inspected prior to use and appeared to be normal.All the marker bands were accounted for at the end of the procedure.The patient is doing fine.One image was received and reviewed.Upon review the marker bands do not appear to be adjacent to the shoulder of the balloon in the image provided but do remain within specification.The device was not returned for analysis.A product history record (phr) review of lot 82160499 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band-balloon catheters- offset/out of position¿ could not be confirmed as the device was not returned for analysis and picture analysis could not confirm out of specification orientation.The exact cause could not be determined.With the information available and without the return of the product or films of the procedure, it is not possible to draw a clinical conclusion between the device and the event.However, vessel characteristics and procedural factors may have contributed to the reported event.According to the device description in the safety information in the instructions for use ¿the cordis saber percutaneous transluminal angioplasty (pta) dilatation catheter is a catheter with a distal inflatable balloon.Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.For balloon lengths greater than or equal to 100mm, the distal section will have one (1) marker band and proximal section will consist of two (2) adjacent marker bands.For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band.The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.¿ neither the phr, picture analysis, nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.Result code (b)(4).
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