Model Number M0062502220 |
Device Problems
Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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Note: this report pertains to one of two navigator hd access sheath devices used in the same patient and procedure.It was reported to boston scientific corporation that two navigator hd access sheath devices were used in the kidney during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, the plastic part of the sheath broke when the scope was passed through the device.The same issue occurred with the second navigator hd access sheath.The procedure was completed with another navigator hd access sheath devices.There were no patient complications reported as a result of this event.
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Event Description
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Note: this report pertains to one of two navigator hd access sheath devices used in the same patient and procedure.It was reported to boston scientific corporation that two navigator hd access sheath devices were used in the kidney during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, the plastic part of the sheath broke when the scope was passed through the device.The same issue occurred with the second navigator hd access sheath.The procedure was completed with another navigator hd access sheath devices.There were no patient complications reported as a result of this event.Additional information received on october 21, 2021: it was clarified that it was the white proximal hub of the device which was broken.
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Manufacturer Narrative
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Block d4, h4: the complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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