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Model Number VA8094 |
Device Problems
Deflation Problem (1149); Peeled/Delaminated (1454)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2021 |
Event Type
Injury
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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: 06/2024).Device pending return.
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Event Description
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It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the balloon flared when trying to remove.There was no patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Therefore, the investigation is inconclusive for the reported deflation problem and material peeling/delamination.The definitive root cause for the reported deflation problem and material peeling/delamination could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 06/2024),.
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Event Description
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It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the balloon flared when trying to remove.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 pta balloon allegedly failed to deflate.It was further reported that while removing the damaged sheath and partially deflated balloon, there was additional damage to the vessel creating larger hole as a result of cannulation.The procedure was completed using another device.The patient current status was unknown.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.The investigation is inconclusive for the reported deflation problem.The definitive root cause for the reported deflation problem could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 06/2024), g3.H11: b5, h1, h6 (patient).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 not returned.
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Search Alerts/Recalls
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