Model Number 6225I |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/23/2015 |
Event Type
malfunction
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Event Description
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It was reported that during implant procedure, the physician had difficulties in deflating the balloon, despite using a syringe.The catheter was attempted and not used.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
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Manufacturer Narrative
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Product event summary: the catheter was returned and analyzed and the mechanical operation of the catheter shaft was bent.Visual analysis indicated the catheter was damaged during use.Catheter is severely kinked and buckled throughout.Balloon will not inflate.Deflate was not tested as a result.Medtronic.
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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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Search Alerts/Recalls
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