BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number M001BP90620B0 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
Hematoma (1884)
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Event Date 07/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).
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Event Description
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It was reported that vessel hematoma occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery(cia).A 2cm peripheral cutting balloon¿ was selected for use.After dilatation was performed, when the device was retrieved into a 7f non bsc introducer sheath, it was noted that the blade of the device cut the sheath and hematoma was noted on the femoral artery.Astriction was performed to stop further bleeding.The physician removed the balloon catheter and the sheath; however, the physician observed difficulties in retrieving the catheter into the sheath.Subsequently, the devices were removed and a new sheath was inserted.The balloon catheter was inspected outside the patient's body and it was noted that only one blade seemed to be rewrapped.A new sheath was inserted to complete the case.No further patient complications and the patient's condition was stable.
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Manufacturer Narrative
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Device evaluated by mfr.,eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated y mfr.: the device was returned for evaluation.The introducer sheath used was not returned.A 6fr introducer sheath was used.It was then noted that the device was unable to insert through the sheath due to the condition of the returned device.Balloon had been inflated as the folds were relaxed and were not re-folded.Blood was evident in the lumen of the device and on the balloon.The balloon was inflated to its rated burst pressure of 10 atmospheres using an encore inflation device to get a better view of the blades.All the blades were intact and no damage was observed.The blades were coated in dry blood.Negative pressure was applied and the balloon deflated without issue.A microscopic and visual examination of the returned device found no kinks or damage along the entire length of the shaft.No other issues were identified during the product analysis.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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It was reported that vessel hematoma occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery(cia).A 2cm peripheral cutting balloon" was selected for use.After dilatation was performed, when the device was retrieved into a 7f non bsc introducer sheath, it was noted that the blade of the device cut the sheath and hematoma was noted on the femoral artery.Astriction was performed to stop further bleeding.The physician removed the balloon catheter and the sheath; however, the physician observed difficulties in retrieving the catheter into the sheath.Subsequently, the devices were removed and a new sheath was inserted.The balloon catheter was inspected outside the patient's body and it was noted that only one blade seemed to be rewrapped.A new sheath was inserted to complete the case.No further patient complications and the patient's condition was stable.
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