SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING
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Model Number 2200-2015 |
Device Problem
Unraveled Material (1664)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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The patient's age at time of event or dob, gender, and weight are unknown.The facility declined to provide this information.The angiosculpt device was unable to deliver to the lesion due to the tortuous anatomy.The physician had to do a guide wire exchange three times in order to complete the procedure with a new balloon device, resulting in prolongation of the case.Patient information regarding relevant tests/laboratory data or medical history is unknown.This information was not available from the facility.The angiosculpt device was returned for investigation.Visual examination found a shaft tear and a lacerated rx port.The tear was located at the intermediate shaft, proximal to the rx port.A section of the core wire protruded from the shaft tear, but remained intact to the device.Based on the complaint details and the returned product investigation, the damaged shaft was likely caused by the improper handling of the device and morphology.
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Event Description
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The angiosculpt device was used together with a asahi, prowater 0.014" guide wire and a medtronic, ebu 6f guide catheter.The angiosculpt was attempted to be delivered to the tortuous anatomy by pushing and twisting, but unable to deliver.The guide wire was removed and switched to different wire (brand unknown), but still unable to deliver, thus the guide wire and device were removed as a unit.Upon removal, the balloon shaft was unraveled.No complications to the patient was reported.
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