Model Number M00542253 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.Fda registration #: (b)(4).
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Event Description
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It was reported to boston scientific corporation that a speedband superview super 7 device was used during a procedure performed on (b)(6) 2019.According to the complainant, the first two bands fired normally; however, the third band snapped prior to firing.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Manufacturer Narrative
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(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Fda registration #: (b)(4).
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Event Description
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It was reported to boston scientific corporation that a speedband superview super 7 device was used during a procedure performed on (b)(6) 2019.According to the complainant, the first two bands fired normally; however, the third band snapped prior to firing.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.***correction** the procedure was performed on (b)(6) 2019.
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Search Alerts/Recalls
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