The customer reported the device was discarded.
Investigation is not yet complete.
A follow up report will be submitted with all additional relevant information.
On january 15, 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter and nc traveler coronary dilatation catheter.
The field safety action number is 2024168-1/27/2020-001.
This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter.
Product from identified lots may exhibit slow, partial or failure to deflate.
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It was reported that on (b)(6) 2020, the patient presented with an st elevated myocardial infarction.
A percutaneous coronary intervention was initiated on the left anterior descending (lad), moderately calcified lesion.
An nc trek (1012453-20, 90923g1) dilatation catheter advanced to the lesion site and inflated without reported issues.
Deflation was attempted; however, the balloon was unable to deflate.
As troubleshooting, the balloon was re-inflated.
The balloon had then ruptured and the lad perforated.
A covered stent was implanted as treatment.
The diagonal coronary artery then ¿shut down¿.
Pericardiocentesis was performed.
On (b)(6) 2020, the patient had expired while in critical care.
No additional information as provided regarding this issue.
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