BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number H74939147251510 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that balloon detachment occurred.The target lesion was located in a vessel below the knee.A 2.5mm x 150mm x 150cm sterling¿ sl balloon catheter was advanced for dilatation.The balloon was inflated at nominal pressure and then deflated without problems.However, during withdrawal of the device, it was noted that the holder with the balloon broke and remained inside the patient's body.Subsequently, a lasso was used to retrieve the remaining component and the procedure was terminated.No patient complications were reported and the patient's status was well.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter in two pieces.The balloon was tightly folded with blood in the balloon, inflation lumen and wire lumen.The tip, balloon, inner/outer shaft, port/exit notch, and hypotube were microscopically and tactile inspected.Inspection revealed a complete separation of the shaft (located 25cm from the tip of the device) and hypotube, numerous kinks in the hypotube and distal outer, and inner shaft damage (buckling located 140mm from the tip of the device).There was numerous kinks and damage that was consistent with excessive tensile force at the site of the separation.The fracture faces of the hypotube were oval, as if kinked prior to separation.Inspection of the remainder of the device revealed no other damage or irregularities.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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It was reported that balloon detachment occurred.The target lesion was located in a vessel below the knee.A 2.5mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.The balloon was inflated at nominal pressure and then deflated without problems.However, during withdrawal of the device, it was noted that the holder with the balloon broke and remained inside the patient's body.Subsequently, a lasso was used to retrieve the remaining component and the procedure was terminated.No patient complications were reported and the patient's status was well.
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