Model Number H7493942812500 |
Device Problems
Deflation Problem (1149); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: the date of the event is unknown.Boston scientific became aware of the event on 30 june 2021.There a date of (b)(6) 2021 was entered to indicate that the event occurred on an unknown day in (b)(6) 2021.
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Event Description
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It was reported that failure to deflate a balloon and balloon damage occurred.A 5.00 x 12mm synergy megatron was used for treatment, but the balloon on the stent would not deflate.It was noted that when the balloon was inspected, it appeared to be mangled.The procedure was completed and no patient complications resulted in relation to this event.
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Manufacturer Narrative
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B3: date of event: the date of the event is unknown.Boston scientific became aware of the event on 30 june 2021.There a date of (b)(6) 2021 was entered to indicate that the event occurred on an unknown day in (b)(6) 2021.Device evaluated by mfr: a 5.00 x 12mm syngery megatron stent delivery system (sds) was returned for analysis.The stent was not returned as it was implanted.The balloon returned in a deflated state.A visual and tactile examination of the hypotube found multiple kinks.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid shaft sections were examined via scope and a tactile examination was performed.The polymer extrusion was stretched 5mm distal to wire port.The inner lumen was bunched 5.4cm proximal to the distal tip.The balloon was inflated to rated burst pressure, but was unable to maintain pressure.A shaft leak was noted 7mm proximal to the first laser cut spiral.The inflation fluid did reach the balloon and no damage was noted on the balloon.The inflation device was verified before and after use.A recommended 0.014 inch guidewire could not be loaded due to the inner lumen damage.No other issues were identified during the product analysis.
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Event Description
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It was reported that failure to deflate a balloon and balloon damage occurred.A 5.00 x 12mm synergy megatron was used for treatment, but the balloon on the stent would not deflate.It was noted that when the balloon was inspected, it appeared to be mangled.The procedure was completed and no patient complications resulted in relation to this event.
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Search Alerts/Recalls
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