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Model Number 51006004L |
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 02/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A review of the manufacturing documentation associated with lot 82219759 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 balloon of saber rx 6mm 4cm 155 was used; however, the balloon ruptured at 8atm while in the superficial femoral artery lesion (sfa).The procedure was completed with a new non-cordis balloon catheter.There was no reported injury to the patient.The device will not be returned for evaluation.Additional information could not be obtained.
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Manufacturer Narrative
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After further review of additional information received the following sections have been updated accordingly: as reported, the balloon of saber rx 6mm 4cm 155 was used; however, the balloon ruptured at eight atm while in the superficial femoral artery lesion (sfa).The procedure was completed with a new non-cordis balloon catheter.There was no reported injury to the patient.Additional information could not be obtained.The device was not returned for evaluation.A product history record (phr) review of lot 82219759 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.Vessel characteristics, although unknown and procedural factors likely contributed to the reported event.However, with the limited amount of information available regarding lesion characteristics and without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.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.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.¿ 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.
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Event Description
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As reported, the balloon of saber rx 6mm 4cm 155 was used; however, the balloon ruptured at 8atm while in the superficial femoral artery lesion (sfa).The procedure was completed with a new non-cordis balloon catheter.There was no reported injury to the patient.The device will not be returned for evaluation.Additional information could not be obtained.
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Search Alerts/Recalls
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