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Model Number 85900P |
Device Problem
Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Internal reference: (b)(4).Facility declined to provide patient information of id, gender, age, and weight.The implant or explant dates are not applicable to this device.Concomitant medical products: no information available.
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Event Description
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This case was reviewed and investigated according to the manufacturer¿s policy.It was reported during an unplanned therapeutic coronary procedure, after four runs, while advancing to the lesion, a catheter detection fail error occurred on the manufacture¿s device.The physician followed the instruction to disconnect and reconnect the catheter and pim, but the problem was not solved.The physician replaced the new catheter then completed the case.There is no patient injury.Femoral access.The returned device was visually and microscopically inspected.A couple of sections of adhesive from the proximal fillet that tapers down on the distal shaft was lifted and has rough edges.It was concluded that the device was missing some adhesive.The probable cause of the observed missing adhesive on the proximal fillet could not be conclusively determined by the investigation.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted because the manufacture¿s device was missing adhesive.It could not be concluded when the separation occurred.There is a potential for harm if the malfunction were to recur.
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Event Description
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This case was reviewed and investigated according to the manufacturer''s policy.Internal reference: (b)(4).This follow-up supplemental report #1 is being submitted to report additional investigation findings, to wit: there is no potential for harm if the malfunction were to recur.This complaint was reassessed based on an engineering study that indicated, this family of catheters do not exhibit any adhesive detachment during normal use.There is no evidence of abnormal use conditions, it is likely the adhesive detached post-procedure, during the process of returning the device for analysis.There was no patient injury, no status decline, no adverse event, and no unplanned additional medical or surgical intervention reported.There is no potential for harm if the malfunction were to recur.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
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Manufacturer Narrative
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H3 other text : placeholder.
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Manufacturer Narrative
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Block h6: supplemental report #1 indicated that the adhesive likely detached post procedure; however, the conclusion code was not updated from 4315 (cause not established) to 4308 (cause traced to transport/storage).
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Search Alerts/Recalls
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