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As reported, during a percutaneous transluminal angioplasty (pta), the user reported a problem with the hub of the pta savvy small vessel 2 x 6 balloon catheter that prevented him to be able to inflate the device.There was no reported patient injury.Additional information received indicated that there was no other product issue noted either at the account after the procedure or prior to shipping for inspection.A better description of the reported hub issue was splintered.Another balloon catheter was used to complete the procedure successfully without patient injury.No target lesion or target lesion characteristic information was provided.No patient information was provided.The product was stored properly per the instructions for use (ifu).There was no reported damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly per the ifu with no problems noted during preparation.The device was not pulled from the packaging by the hub.There was no reported difficulty encountered flushing the sds.There was no difficulty encountered connecting the hub to the indeflator device.The inflation device used was a non-cordis product.The same inflation device was used subsequently with other devices successfully.Attempts were made to inflate the balloon but were not successful.The balloon did not inflate.There was no reported difficulty/resistance during insertion of the device: through the rotating hemostatic valve or through the guiding catheter.Additional information was requested but was reported to be unknown, not applicable (n/a), or was not answered.No additional information is available.One non-sterile unit of pta savvy small vessel 2x6 was received coiled inside a plastic bag.Per visual analysis, the balloon was previously inflated/deflated and dried blood residues were found on the balloon and on the body or received savvy.Also, it was noticed that the hub of the unit was received cracked.No other anomalies or damages were found.An inflation/deflation test was performed and leak was noted in the middle section of the received balloon.Also, a leakage was noted at the savvy hub guide wire port caused by the cracked condition found.Sem results showed that the crack passed through the wall thickness of the hub.Transversal view of the fractured section of the hub showed a fracture pattern that presents evidence of plastic deformations along of the fractured surfaces of the hub commonly found on tensile fractured surfaces.Results also showed that the balloon leakage was caused by a rupture on the balloon surface.The external surface of balloon presented evidence of scratches and abrasion marks near the balloon rupture and it is very likely that the same factors that caused the scratched marks on the balloon outer surface can also contribute to the rupture condition found on the received balloon.The internal surface of the balloon did not present any evidence of damages.No other anomalies were found during sem analysis.A device history record (dhr) review of lot 17665322 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿luer hub cracked¿ and ¿luer hub inflation difficulty - unable¿ were confirmed through analysis of the returned device.Additionally, a balloon rupture/leakage was found during analysis of the balloon as received.The exact cause of the cracked hub, subsequent inflation difficulty and balloon leakage could not be conclusively determined during analysis.Based on the limited information available for review, vessel (although not provided) and procedural/handling factors likely contributed to the balloon leakage and hub crack as evidenced by the scratches found on the balloon, and the plastic deformations found on the hub during sem analysis.According to the instructions for use, which is not intended as a mitigation, ¿balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the result of in vitro testing.At least 99.9% of the balloons (with a 95% confidence level) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specified procedure for which the device will be used.Attach a stopcock to the catheter¿s distal luer port (inflation lumen), marked ¿balloon¿.Attach a 20-cc syringe to the stopcock, open the stopcock and induce negative pressure, pulling the syringe plunger as far back as possible without dislodging it from the syringe barrel.Hold the syringe and proximal end of the dilatation catheter above the distal end of the catheter, and hold the balloon vertically with the balloon tip pointing down.Close the stopcock to the inflation port.Remove the syringe and purge the air.Reattach the 20-cc syringe to the stopcock, open the stopcock and again induce negative pressure.Note: to ensure air contained in the balloon and inflation lumen is removed, it is recommended that negative pressure be induced twice.Open the stopcock only when the syringe is in place with negative pressure maintained.¿ neither the dhr review, nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Additionally, controls are in place on the manufacturing process to inspect for such damages.Therefore, no corrective/preventive action will be taken at this time.Please note that this is the initial/final report for this product.
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As reported, during a percutaneous transluminal angioplasty (pta), the user reported a problem with the hub of the pta savvy small vessel 2 x 6 balloon catheter that prevented him to be able to inflate the device.There was no reported patient injury.The product will be returned for inspection.Additional information received indicated that there was no other product issue noted either at the account after the procedure or prior to shipping for inspection.A better description of the reported hub issue was splintered.Another balloon catheter was used to complete the procedure successfully without patient injury.No target lesion or target lesion characteristic information was provided.No patient information was provided.The product was stored properly per the instructions for use (ifu).There was no reported damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly per the ifu with no problems noted during preparation.The device was not pulled from the packaging by the hub.There was no reported difficulty encountered flushing the sds.There was no difficulty encountered connecting the hub to the indeflator device.The inflation device used was a non-cordis product.The same inflation device was used subsequently with other devices successfully.Attempts were made to inflate the balloon but were not successful.The balloon did not inflate.There was no reported difficulty/resistance during insertion of the device: through the rotating hemostatic valve or through the guiding catheter.Additional information was requested but was reported to be unknown, not applicable (n/a), or was not answered.No additional information is available.Addendum: based on the product evaluation, the product malfunction (pm) code of balloon leakage is being added and the pm code of luer hub - damaged was changed to luer hub-cracked.
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