Catalog Number SGC0302 |
Device Problem
Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.
The device was received.
Investigation is not yet complete.
A follow up report will be submitted with all relevant information.
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Event Description
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This report is filed due to a soft tip tear in the steerable guide catheter.
The steerable guide catheter (sgc) was used during a mitraclip procedure with no reported complaint against this device.
Reportedly the sgc soft tip was not torn.
Subsequently, the sgc was returned to abbott vascular.
Initial analysis of the returned sgc, done on (b)(6) 2018, noted that the soft tip of the sgc was torn.
All soft tip material seemed to be present.
There was no reported adverse patient effect due to the soft tip tear.
No additional information was provided regarding this sgc issue.
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Manufacturer Narrative
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(b)(4).
Evaluation summary: all available information was investigated and the steerable guide catheter (sgc) was noted to have a soft tip tear.
The observed torn soft tip was a result of the clip getting caught on the guide tip; therefore, attributed to procedural conditions.
A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this complaint.
Additionally, a review of the complaint history identified no other incident reported from this lot.
There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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