Model Number 9004 |
Device Problems
Material Separation (1562); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 04/2023).
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Event Description
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It was reported that during an angioplasty procedure, the drug coated balloon allegedly failed to thread over the guidewire.It was further reported that guidewire was stiff and white residue/fibers coming out the end of the balloon and covering wire.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: (expiry date: 04/2023).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that during an angioplasty procedure, the drug coated balloon allegedly failed to thread over the guidewire.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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