BARD PERIPHERAL VASCULAR, INC. DORADO PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Model Number DR8044 |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one dorado pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device appeared bloody and no other anomalies were noted.On the functional evaluation, an in-house presto inflation device was used to inflate the balloon but was unable to be inflated or maintain pressure.The catheter shaft was then cut multiple times and attached to a touhy adapter to be inflated but was still unable to inflate.The catheter was examined under magnification, the dried blood and contrast was noted in the catheter.The circumferential break was also noted at the proximal balloon joint.No further testing was performed.Therefore the investigation for the reported leakage remains inconclusive, as the functional testing was not performed due to the contrast medium and the blood that was noted to be dried inside the inflation lumen of the returned device.The investigation for the identified circumferential break was confirmed, as the break was noted at the proximal balloon joint under the microscopic observation.A definitive root cause for the reported leakage and the identified circumferential break could not be determined based upon the provided 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.(expiry date: 12/2023).
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Event Description
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It was reported that during angioplasty procedure through superficial femoral artery via cfa/popliteal, the balloon allegedly had leakage.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one dorado pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device appeared bloody and no other anomalies were noted.On the functional evaluation, an in-house presto inflation device was used to inflate the balloon but was unable to be inflated or maintain pressure.The catheter shaft was then cut multiple times and attached to a touhy adapter to be inflated but was still unable to inflate.The catheter was examined under magnification, the dried blood and contrast was noted in the catheter.The circumferential break was also noted at the proximal balloon joint.No further testing was performed.Therefore the investigation for the reported leakage remains inconclusive, as the functional testing was not performed due to the contrast medium and the blood that was noted to be dried inside the inflation lumen of the returned device.The investigation for the identified circumferential break was confirmed, as the break was noted at the proximal balloon joint under the microscopic observation.The identified circumferential break is likely the root cause for the reported leakage.However, the definitive root cause for the reported leakage and the identified circumferential break could not be determined based upon the provided 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: 12/2023), g3.H11: e1(initial reporter city).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 : see h10.
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Event Description
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It was reported that during an angioplasty procedure through superficial femoral artery via cfa/popliteal, the balloon allegedly had leakage.There was no reported patient injury.
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Search Alerts/Recalls
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