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Model Number M0063901050 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2021 |
Event Type
malfunction
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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 the kidney during a stone retrieval procedure performed on (b)(6) 2021.During procedure, the sheath frayed at the distal section where the basket meets the sheath.The procedure was completed with this device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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The complainant was unable to report the lot number; therefore, the manufacture date and the expiration date are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch 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 the kidney during a stone retrieval procedure performed on (b)(6) 2021.During procedure, the sheath frayed at the distal section where the basket meets the sheath.The procedure was completed with this device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and the expiration date are unknown.Block h6: device code a0414 captures the reportable event of sheath torn at the distal end.Block h10: the returned zero tip basket was analyzed, and a visual inspection noted that the device working length was in good condition.Functional inspection found the device will open and close.A picture of the device was submitted and no damage was observed.The reported event was not confirmed.Visual and functional test of the complaint device did not identify any evidence of either the alleged issue or any defect on the device.Based on all available information, the most probable cause is no problem detected.A device history record (dhr) review was unable to be performed as the lot number is unknown and a ship history review was unable to identify a most probable lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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Search Alerts/Recalls
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