Catalog Number 48506050 |
Device Problems
Leak/Splash (1354); Material Rupture (1546)
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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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The catalog number identified in section has not been cleared in the us, but is similar to the bantam otw pta catheter products that are cleared in the us.The pro code for the bantam otw pta catheter products is identified.As the lot number was provided, a lot history review will be performed.The sample was not returned for evaluation, therefore the investigation is inconclusive for the alleged leak and material rupture issues.The root cause could not be determined.The device was labeled for single use.
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Event Description
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This report summarizes one malfunction.A review of reported information indicates that model 48506050, pta balloon dilatation catheter, allaged experienced leak and material rupture.This information was recieved from a single source.This malfunction involved a (b)(6) female patient with no consequences.The patient's weight was not provided.
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Event Description
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This report summarizes one malfunction.A review of reported information indicates that model 48506050, pta balloon dilatation catheter, alleged experienced leak and material rupture.This information was received from a single source.This malfunction involved a 70 year old female patient with no consequences.The patient's weight was not provided.
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Manufacturer Narrative
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H10: of the reported malfunction, the file was reassessed for reportability and determined to be no longer reportable.The catalog number identified in section d4 has not been cleared in the us, but is similar to the bantam otw pta catheter products that are cleared in the us.The pro code for the bantam otw pta catheter products is identified in d2.As the lot number was provided, a lot history review will be performed.The sample was not returned for evaluation, therefore the investigation is inconclusive for the alleged leak and material rupture issues.The root cause could not be determined.The device was labeled for single use.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.
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Search Alerts/Recalls
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