BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 87035 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); Hematoma (1884); Pain (1994); Swelling (2091)
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Event Date 08/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Lot number was not provided; therefore, a ship history of previous lots sent to the customer was reviewed.Device history record (dhr) review of the lots identified found no issues.
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Event Description
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It was reported that the patient experienced a right femoral arteriovenous (av) fistula.One hour after completion of an atrial fibrillation (af) ablation procedure with an intellanav mifi oi large curve and an intellamap orion catheter, the patient presented with a right femoral av fistula.Pain and swelling with hematoma was present.Only venous access was used during the procedure.The patient was brought to the vascular lab where the fistula was documented with contrast injection from ipsilateral femoral artery.An arterial stent was then placed by the physician, closing the fistula.2 ea 9 fr 12 cm sheaths, 1 ea 8.5 french sl0, and 1 ea non-boston scientific were used for access in right groin.Doppler ultrasound was used with all initial sheath / venous access.
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