Model Number H7493895915200 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/07/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years old or older.(b)(4).Device evaluated by mfr.: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 2.00mm x 15mm apex¿ balloon catheter was advanced for dilatation.However, upon introduction, the shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a apex balloon catheter.The balloon was tightly folded.There was contrast in the inflation lumen.There was blood in between balloon folds.The outer shaft, inner shaft, balloon and tip were microscopically examined.There were numerous hypotube kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
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Event Description
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It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 2.00mm x 15mm apex¿ balloon catheter was advanced for dilatation.However, upon introduction, the shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported.
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Search Alerts/Recalls
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