Model Number U41502H22 |
Device Problems
Peeled/Delaminated (1454); Material Rupture (1546)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The device has been returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.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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Event Description
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This report summarizes one(1) malfunction event.A review of the event indicated that model u41502h22 pta dilatation catheter allegedly experienced the outer layer of the balloon peeling after removing the balloon from a hep-saline bowl.The procedure was completed with another balloon.This report was received from one source.This event involved one patient whose age, weight and gender were not provided.There was no patient contact.
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Event Description
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This report summarizes one (1) malfunction.A review of the reported information indicated that model u41502h22 pta dilatation catheter allegedly experienced the outer layer of the balloon peeling after removing the balloon from a hep-saline bowl.The procedure was completed with another balloon.This report was received from one source.This event involved one patient whose age, weight and gender were not provided.There was no patient contact.
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Manufacturer Narrative
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H10: the lot number was provided for the single returned device and a lot history review was performed.A longitudinal rupture was noted on distal cone of the balloon on the device.A root cause has not been determined.The device was labeled for single use.H11: h6 (device code 2, results 1, conclusion 1).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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