Catalog Number TPW10 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: did the pacing wire break post-operatively? they believe so yes.How was it confirmed that the pacing wire was broken? the pacing machine was alarming saying it couldn't pace.Was there any medical/surgical intervention done to address the broken pacing wire? they just replaced with a new wire.No surgical intervention needed.Was the new pacing wire on standby to fit inserted on the patient in a separate procedure to address the broken pacing wire? no additional procedure needed.Any device available to return for evaluation? yes but its with smtl in wales for testing at the moment.
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Event Description
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It was reported that a patient underwent an unknown procedure on an unknown date and a temporary pacing wire was used.The wire frayed whilst in situ.The pacing wire broke on the blue insulated wire.It happened at some point between arrival in itu and moved into hdu.It was noted that the pacing machine was alarming saying unable to pace.They had a new pacing wire on standby to fit.No adverse outcome to patient.No extra procedure required.Additional information was requested.
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Manufacturer Narrative
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Product complaint # (b)(4).Additional evaluation summary: it was received for analysis two needle-suture pieces and a suture piece of product code tpw10.During the visual inspection of the dispensed samples, the swage and attachment area of needles were as expected; however damage on the coated of polyethylene from strand was observed and the ends were cut.Due to condition of the samples received no functional test could be performed.The assignable cause suggests an improper handling of the sample.
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Search Alerts/Recalls
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