Model Number 9004 |
Device Problems
Difficult to Remove (1528); Material Rupture (1546); Failure to Advance (2524); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2022 |
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: 02/2024).
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Event Description
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It was reported that during an angioplasty procedure, the device was allegedly could not be advanced in the patient.It was further reported that guidewire was stuck on the balloon and it could not be removed.Reportedly, the balloon was shrunk and broke while the wire was removed from the balloon.The procedure was completed by using another device.There was no reported patient injury.
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Event Description
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It was reported that during an angioplasty procedure, the device was allegedly could not be advanced in the patient.It was further reported that guidewire was stuck on the balloon and it could not be removed.Reportedly, the balloon was shrunk and broken when separate the balloon from the wire.The procedure was completed by using another device.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# 3006513822-2022-00012 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# 3006513822-2022-00011.H10: d4 (expiry date: 02/2024), g3.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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