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Model Number 2200-3515 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The patient's weight is unknown.This information was not available from the facility.During removal, the angiosculpt device separated in two pieces.Recurrence of the malfunction could result in patient harm.No patient injury reported.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The angiosculpt device was returned for evaluation.Visual inspection found a missing distal tip and a device separation at the intermediate shaft, approximately 2 cm distal to the hypotube.Resistance was noted during delivery; however, the user proceeded to use the relevant device.Per the ifu, if unusual resistance is felt when the catheter is being manipulated, carefully remove the entire catheter system as a unit.
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Event Description
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It was reported that during a coronary procedure, resistance was noted during delivery of the angiosculpt device.Upon removal, the shaft broke in two pieces and the device was removed intact to the guide wire with no additional intervention.The procedure was aborted due to the patient not being a good candidate and the procedure was completed from an interventional standpoint.No patient injury reported.
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Manufacturer Narrative
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Block h6: in the initial mdr, investigation conclusion code 61 was added.However, upon further review, it was determined that this code does not apply.The user followed the ifu and did not proceed with the relevant device when resistance was noted.
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Search Alerts/Recalls
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