Catalog Number SPL25020X |
Device Problems
Deflation Problem (1149); Difficult to Remove (1528)
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Patient Problems
Intimal Dissection (1333); Fever (1858); Chest Tightness/Pressure (2463)
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Event Date 03/19/2019 |
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 a procedure an attempt was made to use a sprinter legend rx ptca balloon catheter to treat a non-tortuous, mildly calcified lesion exhibiting 80% stenosis located in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed without issue.The lesion was pre-dilated.Resistance was not encountered when advancing the device and excessive force was not used during delivery.It was reported that balloon deflation difficulties were experienced.The device was slow to deflate at the lesion site and could not be removed through the catheter.Repeated attempts were made to remove the device, resulting in a slight tear in the inner wall of the vessel.It was reported that the heartbeat and blood pressure of the patient were noted to be abnormal during the procedure and it is indicated that the patient felt unwell.After the procedure it was reported that the patient had a fever which resolved after two days.The patient is reported to be alive with no further injury.
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Manufacturer Narrative
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Additional information:no abnormal blood pressure noted.It is stated that difficulties were noted when removing the protective sheath.No difficulties were noted removing the packaging stylette.No difficulties noted during inflation.The deflation difficulties were encountered after the first inflation.The deflation time was at least 5 minutes.Various methods were used to deflate the balloon including pumping with a syringe.Finally, when the balloon was filled with contrast slightly less, the catheter was pulled out together with the guiding catheter, and the balloon was still filled with contrast after being pulled out.The patient had chest tightness and chest pain.1:1 ratio contrast / saline was used.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Device evaluation summary: the balloon returned fully deflated.There was no deformation to the balloon material.Stretching was evident to the material at the balloon bond causing a narrowing of the inflation lumen material.It was not possible to inflate the device to perform deflation testing due to the stretching on the material at the balloon bond.There was slight deformation to the distal shaft and inner member.There was no deformation to the distal tip.The sheath and stylette were not returned with the device.Image review summary: an image of the complaint device was received for analysis.The image shows the luer of the device, the balloon and a portion of the hypotube and distal shaft.There is no deformation to the device visible in the image.The lot number on the luer matches what was reported.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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