Catalog Number SPL15020X |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
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Event Date 10/16/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During the procedure, an attempt was made to use one sprinter legend rx coronary ptca balloon catheter to treat a severely tortuous and calcified lesion exhibiting 99% stenosis located in the mid lad.The device was inspected with no issues.(b)(6) prep was performed with no issues.The device did not pass through a previously deployed stent.The lesion was not pre-dilated.Resistance was encountered when advancing the device however excessive force was not used.It was reported that during the procedure the balloon was inflated to 8atm and a balloon rupture occurred inside the patient.The mid marker band dislodged into the septal perforator coronary artery.Balloon debris and the mid marker band remain inside the patient.The procedure was completed by rotational atherectomy and stenting.The patient was discharged.The patient is reported to be alive with injury.
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Add info: there was attempt to remove the marker band from the patient¿s body.The patient did not suffer any injury.Product analysis summary: the device returned with blood visible in the balloon and inflation lumen.The distal tip was detached.The material at the detachment site was jagged and uneven.Damage was evident to the balloon material at the burst site.The inner member was severely stretched.There was a detachment of the balloon material.The material at the detachment site was jagged and uneven.The mid marker was not present.There was no damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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