Catalog Number AI-07155-IK |
Device Problems
Intermittent Capture (1080); Material Too Soft/Flexible (4007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that during procedure, the doctor noted that the wire provided in the catheter kit was flimsy and difficult to control and doesn't provide a consistent capture/sensing.As a result, the wire was removed, and a new wire was used.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No parts was returned to teleflex chelmsford for investigation.The reported complaint that the "wire is really flimsy and difficult to control" is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
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Event Description
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It was reported that during procedure, the doctor noted that the wire provided in the catheter kit was flimsy and difficult to control and doesn't provide a consistent capture/sensing.As a result, the wire was removed, and a new wire was used.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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