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Catalog Number CQ7554J |
Device Problems
Difficult to Remove (1528); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the conquest products that are cleared in the us.The pro code and 510k number for the conquest products is identified in d2 and g4.H10: 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.H10: d4 (expiration date: 06/2026).H11: section a through f ¿ the information provided by bd represents all 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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Event Description
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It was reported that during an angioplasty procedure, after complete expansion, when the pta balloon was tried to be removed, the balloon allegedly didn't move at all.It was further reported that further a stronger force was tried to remove the balloon however, there had a possibility that the guidewire would break.Reportedly the balloon was removed with the guidewire.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: the catalog number identified in section d4 has not been cleared in the us but is similar to the conquest products that are cleared in the us.The pro code and 510k number for the conquest products is identified in d2 and g4.H10: d4 (expiration date: 06/2026), g3, h6 (device).H11: section a through f ¿ the information provided by bd represents all 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, after complete expansion, when the pta balloon was tried to be removed, the balloon allegedly didn't move at all.It was further reported that a stronger force was tried to remove the balloon, however, there had a possibility that the guidewire would break.Reportedly, the balloon was removed with 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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