Catalog Number UNK 014 HI-TORQUE PILOT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intimal Dissection (1333); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Myocardial Infarction (1969); Occlusion (1984); Perforation (2001); Vasoconstriction (2126)
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Event Date 01/01/2013 |
Event Type
Injury
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Manufacturer Narrative
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Date estimated.The patient deaths referenced will be filed under a separate medwatch report #.The additional devices referenced will be filed under separate medwatch report numbers.There was no reported device malfunction and the product was not returned.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review for this product was not performed since the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of perforation, myocardial infarction, dissection, occlusion, and infection are listed in the instructions for use guide wire hi-torque pilot, as known patient effects of the procedure.A conclusive cause for the reported perforation, myocardial infarction, intimal dissection, occlusion, hypersensitivity, hemorrhage, vasoconstriction, hypotension, hypertension, and infection and the relationship to the product, if any, cannot be determined.Additionally, treatments and hospitalization appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The udi is unknown as the part and lot numbers were not provided.Article title: post market clinical follow-up evaluation report polymer guide wiresna.
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Event Description
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It was reported through a research article identifying whisper, pilot, and progress guide wires that may be related to the following: patient death, myocardial infarction, perforation, dissection, occlusion, allergic reaction, bleeding, vasoconstriction, hypotension, hypertension, infection, revascularization, and rehospitalization.This article summarizes clinical outcomes of (b)(4) patients that were treated with whisper, pilot, and progress guide wires.Specific patient information is documented as unknown.Details are listed in the attached article, titled "post market clinical follow-up evaluation report polymer guide wires.".
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Search Alerts/Recalls
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