Catalog Number IAV05008008P |
Device Problems
Burst Container or Vessel (1074); Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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A physician was attempting to use an inpact av drug coated balloon (dcb) for treatment of a 6omm fibrous plaque lesion in the left upper arm shunt blood vessel.The vessel was 8mm in diameter with moderate tortuosity and calcification.A 7fr non medtronic sheath and a 0.045 150cm non medtronic guidewire was used.Embolic protection was not used.A syringe was used for inflation with contrast agent saline 5:5.The device was prepped as per the ifu with no issues identified.The device did not pass through a previously deployed stent.No resistance was encountered during delivery.It was reported the inpact av was inserted through the sheath to inflate the shunt vessel; when the deployment began according to the procedure, inflation difficulties were noted at 6 atm on cycle 1 and the balloon ruptured at 8atm.All fragments were retrieved.No patient injury was reported.
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Manufacturer Narrative
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Additional information: the balloon did not fragment, since the balloon part was not separated from the catheter, the catheter was removed as it was.No vessel damage was reported.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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