BOSTON SCIENTIFIC - MAPLE GROVE THREADER¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number H7493926912120 |
Device Problem
Kinked (1339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: returned product consisted of a threader balloon catheter.The balloon was tightly folded.There was contrast in the inflation lumen.Device analysis determined the condition of the returned device was consistent with the complaint incident.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube shaft was completely separated 68.5 cm from the tip.The fracture faces were oval as if kinked prior to separation.There were numerous hypotube kinks.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Event Description
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Reportable based on device analysis completed on 15-dec-2016. it was reported that shaft kink were encountered. the 75% stenosed target lesion was located in a very tight, moderately tortuous and moderately calcified coronary artery.A 1.2mm x 12mm threader¿ balloon catheter was advanced for dilatation however, the shaft kinked.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine. however, returned device analysis revealed hypotube break.
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