Model Number DBP-150SOLID145 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/30/2023 |
Event Type
Injury
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Event Description
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Following atherectomy using a diamondback 360 peripheral orbital atherectomy device (oad), angiographic imaging observed a type c dissection in the distal superficial femoral artery (sfa).
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Manufacturer Narrative
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H6 investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use manual states that vascular dissection is a potential adverse event that may occur and/or require intervention with use of the system.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).
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Manufacturer Narrative
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Correction: core lab angiographic imaging review identified a type c dissection related to the orbital atherectomy system.H6 investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use user manual states that vascular dissection is a potential adverse event that may occur and/or require intervention with use of the system.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id:(b)(4).
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Manufacturer Narrative
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Csi device did not cause or contribute to the dissection, therefore this event is no longer reportable for the csi device.Csi id: (b)(4).
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Event Description
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Additional information: dissection was not treated.According to the physician, csi device did not cause or contribute to the dissection.The patient was stable.
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Search Alerts/Recalls
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