BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Model Number CQ7584 |
Device Problem
Deflation Problem (1149)
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Patient Problems
Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2021 |
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 will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 07/2023).
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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 another balloon was used to complete the procedure.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 another balloon was used to complete the procedure.A needle intervention was used to deflate the balloon.The current status of the patient unknown.
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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 will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date: 07/2023.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, the pta balloon allegedly failed to deflate.It was further reported that a needle was penetrated into the patient skin to deflate the balloon.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the deflation issue could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11: section a through f ¿ the information provide 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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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the original reported device was not returned for the evaluation.Two conquest sealed lot samples has been received for the evaluation.On the visual evaluation, the lot sample1 was appeared to be clean and no other specific anomalies were noted to the device.On the functional evaluation, the balloon was inflated to 8atm using an in-house presto inflation device.The balloon was inflated and maintained pressure without any issue.Further, the balloon was deflated without any issue and deflated within 9 seconds which is below the maximum deflation time in the product performance specification limit.Therefore the investigation for the reported deflation issue for the original affected device remains inconclusive, as the device was not returned for the evaluation.However the investigation for the reported deflation issue for the returned lot sample was also remains inconclusive, as the original device not returned for the evaluation and the device deflated without any issue during the functional testing.A definitive root cause for the deflation issue could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 07/2023), g3, h2.H11: h6 (method).H11: section a through f ¿ the information provide 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 : see h10.
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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 a needle was penetrated into the patient skin to deflate the balloon.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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