Model Number ATG120164 |
Device Problems
Deflation Problem (1149); Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2022 |
Event Type
malfunction
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Event Description
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It was reported that during an angioplasty procedure in the iliac vein, the pta balloon allegedly had inflation and deflation issue.There was no reported patient injury.
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
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Manufacturer Narrative
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H10: this supplemental mdr is being submitted to report that mfr rpt# 2020394-2022-00255 was a duplicate record and was opened in error.The event details are being captured under complaint file # (b)(4) and was reported to the fda under mfr rpt# 2020394-2022-00160.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 in the iliac vein, the pta balloon allegedly had inflation and deflation issue.There was no reported patient injury.
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Search Alerts/Recalls
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