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Model Number 20226 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/29/2023 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.A 10.0x60x75cm express ld iliac / biliary stent was advanced for treatment.However, during deployment, the balloon seemed to have burst.Upon removal, it appeared as though there was a small hole in the part of the balloon.The device was removed from sterile field, wiped twice, and bagged twice.It was noted that the physician was not concerned about any pieces of the balloon remaining in the patient.No patient complications were reported.
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Manufacturer Narrative
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The complaint was received for analysis.A visual examination of the returned device confirmed that the balloon had been subjected to positive pressure.Blood was observed inside the balloon which is evidence of a device leak.A leak test identified a pinhole in the balloon material located approximately 7mm proximal of the distal markerband.No other issues were noted with the balloon material.The device was received with stent fully deployed from the delivery system as it was implanted inside the patient.A visual examination identified no issues with the tip that could potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.
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Event Description
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It was reported that balloon rupture occurred.A 10.0x60x75cm express ld iliac / biliary stent was advanced for treatment.However, during deployment, the balloon seemed to have burst.Upon removal, it appeared as though there was a small hole in the part of the balloon.The device was removed from sterile field, wiped twice, and bagged twice.It was noted that the physician was not concerned about any pieces of the balloon remaining in the patient.No patient complications were reported.
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Search Alerts/Recalls
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