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Model Number M0063901050 |
Device Problem
Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a zero tip¿ basket was used in a procedure performed on (b)(6) 2018.According to the complainant, during procedure, it was noticed that the sheath near the basket was frayed.The device was unable to be used.The procedure was successfully completed with another zero tip¿ basket.There were no patient complications reported as a result of this event.The patients¿ condition at the conclusion of the procedure was said to be ¿no injury to the patient¿.
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Search Alerts/Recalls
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