Model Number 006173P |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354); Material Puncture/Hole (1504)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that damage was found on the balloon of the temporary pacing electrode catheter prior to placement.It was later reported via email on 19 december 2019 from the international business center representative, that a small hole was found on the balloon, which allegedly caused leaks during pretest.
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Event Description
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It was reported that damage was found on the balloon of the temporary pacing electrode catheter prior to placement.It was later reported via email on 19 december 2019 from the international business center representative, that a small hole was found on the balloon, which allegedly caused leaks during pretest.
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Manufacturer Narrative
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The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to an "inappropriate package design".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "when using a balloon catheter, use care when removing the protective sleeve from the distal portion of the catheter.Forced removal of this protective sleeve may result in damage to the balloon and the catheters structural integrity." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Search Alerts/Recalls
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