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Model Number M0063901010 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/04/2020 |
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.
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Event Description
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It was reported to boston scientific corporation that a zero tip basket was unpacked on (b)(6) 2020.According to the complainant, at the side of the label inside the packaging was black and dirty, which was confirmed via a photo submitted by the customer.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Search Alerts/Recalls
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