Catalog Number AK-45703-CDC |
Device Problem
Unraveled Material (1664)
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Patient Problems
Pneumothorax (2012); No Consequences Or Impact To Patient (2199)
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Event Date 01/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
The results of the investigation are incomplete at the time of this report.
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Event Description
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The customer alleges that the wire unraveled becoming too weak to thread the sheath and causing a sharp end that bent sideways during removal.
No patient injury or consequence reported.
The patient's condition is reported as fine.
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Manufacturer Narrative
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(b)(4).
Complaint verification testing could not be performed as no sample was returned for analysis.
The device history records (dhr) for the guide wire were reviewed with no evidence to suggest a manufacturing related cause.
The potential cause of guide wire unraveling could not be determined based upon the information provided and without a sample.
If the sample is returned, a follow-up report will be submitted with investigation results.
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Event Description
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The customer alleges that the wire unraveled becoming too weak to thread the sheath and causing a sharp end that bent sideways during removal.
No patient injury or consequence reported.
The patient's condition is reported as fine.
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Manufacturer Narrative
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(b)(4).
Additional information received via review of the maude database (report #(b)(4)).
It was reported that the patient suffered a pneumothorax.
This required insertion of a chest tube and prolonged hospitalization to recover.
The customer was contacted over the phone and verified that this information was correct.
The customer also stated this information was unknown to her at the time the complaint was submitted to the sales rep.
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Search Alerts/Recalls
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