Model Number DR13568 |
Device Problems
Peeled/Delaminated (1454); 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 sample was returned for evaluation.The sample was appeared to be clean.No kinks or anomalies to the luers, bifurcate or glue fillets.Peeled pebax was noted to the balloon approx.9.3cm from the distal tip.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model dr13568 pta balloon dilatation catheter allegedly experienced delamination and a material rupture.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient was reported to be (b)(6), weight and gender were not provided.
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Manufacturer Narrative
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The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the investigation is confirmed for peeling and material rupture.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model dr13568 pta balloon dilatation catheter allegedly experienced delamination and a material rupture.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient was reported to be 74-years-old, weight and gender were not provided.
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Search Alerts/Recalls
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