Model Number 977A260 |
Device Problems
Difficult to Insert (1316); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/22/2019 |
Event Type
malfunction
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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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Information was received from a manufacturer representative.It was reported that the physician put a slight bend in the stylet.It was reported that the stylet would only go in 2 ¿ 3 mm.The manufacturer representative stated that when looking at the bend in the stylet, it would not have created the issue.The manufacturer representative stated that the ¿lumen did not look right.¿ there was no patient involvement and no symptoms or complications were reported.
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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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Additional information received from a manufacturer representative (rep).It was reported that the lumen did not look like they normally when the rep looked at it closely.The rep said the stylet was taken out, an additional bend was put in it, and then it wouldn't go back in.They didn't know why it wouldn't go back in.The lead was going to be returned for analysis.No further complications were reported.
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Manufacturer Narrative
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Analysis of the lead determined that there was a foreign material blocking the insertion of the stylet.If information is provided in the future, a supplemental report will be issued.
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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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Additional information was received from a manufacturer representative (rep) indicating that they would send the lead back today.They will provide a tracking number after it is shipped.No further complications were reported.
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Search Alerts/Recalls
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