Model Number M001BP90820B0 |
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 Type
malfunction
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Event Description
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It was reported that a cutting balloon blade was hanging off.An 8.00mm / 2.0cm / 90cm 2cm peripheral cutting balloon¿ was used to treat a fistula containing a previously implanted stent.After removing the balloon from the sheath after use, it was noticed that one of the dermatomes was not completely adhered to the balloon.The procedure was completed with this device.No patient complications were reported and the patient's status was fine.
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Manufacturer Narrative
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(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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Manufacturer Narrative
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Device evaluated by manufacturer: investigation completed.The device was returned for analysis.A visual examination noted that one blade had detached from the balloon; however, the blade pad was still fully intact.The three remaining blades were fully bonded to the balloon and no damage was noted to the blades.The returned device was attached to an encore inflation unit.Positive pressure was applied.No leak was noted.The balloon was inflated to its rated burst pressure.The balloon inflated and deflated successfully.Visual and tactile examination of the shaft observed no kinks or damage.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 a cutting balloon blade was hanging off.An 8.00mm / 2.0cm / 90cm 2cm peripheral cutting balloon was used to treat a fistula containing a previously implanted stent.After removing the balloon from the sheath after use, it was noticed that one of the dermatomes was not completely adhered to the balloon.The procedure was completed with this device.No patient complications were reported and the patient's status was fine.
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Search Alerts/Recalls
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