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Model Number M00522610 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
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Event Date 08/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Health professional was approximated to yes as the initial reporter name and occupation are unknown, but the event was reported to have occurred at a health care facility.(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that three resolution clip device were used during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip was fired and the material broke inside the patient.The same issue occured with the second and third resolution clip device.No patient complications have been reported as a result of this event.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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Block e1: initial reporter fax: (b)(6).Block e2: health professional was approximated to yes as the initial reporter name and occupation are unknown, but the event was reported to have occurred at a health care facility.Block h6: medical device problem code a15 captures the reportable event of when firing clip broke.Block h10: investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the clip assembly was not returned and the device had evidence of a full deployment.Microscope examination was performed, and no issues found on the device.Dimensional examination was performed on the bushing outside diameter, and it was observed to be within specification.A dimensional examination was performed between the hooks of the bushing, and it was found that sides a and b were out of specification.No other issues with the device were noted.The reported event was not confirmed.The device returned without the clip assembly and it is important to mention that the presence of this component is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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Event Description
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It was reported to boston scientific corporation that three resolution clip device were used during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip was fired and the material broke inside the patient.The same issue occured with the second and third resolution clip device.No patient complications have been reported as a result of this event.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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