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Model Number M00522610 |
Device Problems
Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Initial reporter's alternative phone number: (b)(6).Imdrf device code a15 captures the reportable event of clip did not deploy from catheter.
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Event Description
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It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the clip did not deploy from the catheter despite the proper techniques for deployment were initiated.The procedure was completed with another resolution clip.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h2: additional information: block b5 (describe event or problem), e1 (initial reporter first name, phone number and email), h6 (device codes) and h10 (additional mfr narrative) have been updated based on the additional information received on april 3, 2023.Block h6: imdrf device code a15 captures the reportable event of clip did not deploy from catheter.
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Event Description
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It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the clip did not deploy from the catheter despite the proper techniques for deployment were initiated.The procedure was completed with another resolution clip.There were no patient complications reported as a result of this event.Additional information received on april 3, 2023: note: this report pertains to one of two resolution clips used in the same patient and procedure.It was reported that the procedure performed was a routine colonoscopy procedure.Both clips had problems advancing out of the over sheath.When the clips eventually were able to advance out of the sheath, the clips did not fire properly.
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Event Description
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It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the clip did not deploy from the catheter despite the proper techniques for deployment were initiated.The procedure was completed with another resolution clip.There were no patient complications reported as a result of this event.Additional information received on april 3, 2023: note: this report pertains to one of two resolution clips used in the same patient and procedure.It was reported that the procedure performed was a routine colonoscopy procedure.Both clips had problems advancing out of the over sheath.When the clips eventually were able to advance out of the sheath, the clips did not fire properly.
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Manufacturer Narrative
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Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a15 captures the reportable event of clip did not deploy from catheter.Block h10: investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly and with evidence of full deployment.Microscopic examination was performed, and it was found that the bushing had hit marks.Functional evaluation could not be performed due to the lack of clip assembly.A dimensional analysis was performed between the hooks of the bushing and both sides were noted to be within specification.No other problems with the device were noted.The reported event of clip did not deploy from catheter was not confirmed.Investigation found that the device was returned without the clip assembly and with evidence of full deployment, indicating that the clip did release from the catheter.Regarding the hit marks found on the bushing, this is likely due to the interaction between the yoke and the capsule, in order to deploy the clip.However, it is important to mention that the presence of the clip assembly is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.Additionally, it is important to take into consideration that during the product analysis, the dimensions between the hooks of the bushing were measured, and they were within specification, excluding the possibility that the device components dimensions interfered with the device performance.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.
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Search Alerts/Recalls
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