Model Number VA80104 |
Device Problem
Detachment of Device or Device Component (2907)
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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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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 01/2025).
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Event Description
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It was reported that during an angioplasty procedure in the upper arm fistula, the tip of the balloon allegedly broke off upon inflation.It was further reported that the tip of the balloon was retrieved with a snare.There was no reported patient injury.
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Event Description
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It was reported that during an angioplasty procedure in the upper arm fistula, the tip of the balloon allegedly broke off upon inflation.It was further reported that the tip of the balloon was retrieved with a snare.There was no reported patient injury.
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Manufacturer Narrative
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H10: this supplemental mdr is being submitted to report that mfr rpt# 2020394-2022-00254 was a duplicate record and was opened in error.The event details are being captured under complaint file # 4672141 and was reported to the fda under mfr rpt# 2020394-2022-00239.H10: d4 (expiry date: 01/2025).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.H3 other text : device pending return.
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Search Alerts/Recalls
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