BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number H7493892820200 |
Device Problem
Kinked (1339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/07/2016 |
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 maverick 2 balloon catheter in two pieces.The balloon was tightly folded and there was blood in the lumen.The hypotube and inner/outer shaft was microscopically examined.The hypotube broke/fractured 60cm from the strain relief with a kink at 56cm from the strain relief.The fracture faces were oval as if kinked prior to separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 27-jul-2016.It was reported that shaft kink occurred.The 90% stenosed, 18mm x 2.5mm target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery.A 2.00mm x 20mm maverick 2 (tm) balloon catheter was advanced for dilatation.However, during the procedure, it was noted that the shaft was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a hypotube break.
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