BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS; CATHETER, PERIPHERAL, ATHERECTOMY
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Model Number 29720 |
Device Problems
Entrapment of Device (1212); Intermittent Loss of Power (4016)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/03/2020 |
Event Type
malfunction
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Event Description
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It was reported that the burr was unable to retract over the wire.The target lesion was located in the severely calcified superficial femoral artery (sfa).A 2.00mm peripheral rotalink plus and a peripheral rotawire were selected for use.During procedure, the burr stalled on two occasions.Subsequently, upon withdrawal, it was noted that the burr could not be retracted over the rotawire.The devices were able to be removed as a single unit from the patient's body, but lost wire access wire across the lesion.A new access was obtained and successful angioplasty was performed to complete procedure.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a rotablator plus device with a guidewire inside of it.The burr catheter was attached to the advancer when received.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.Visual and microscopic examination revealed no damages.Functional testing was performed by rotating the drive shaft and it was unable to rotate.The device was disassembled and the ultem was melted while the turbine is corroded.The guidewire was removed and analyzed under complaint (b)(4).Inspection of the remainder of the device presented no damage or irregularities.Product analysis found that the ultem is melted and the turbine is corroded.
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Event Description
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It was reported that the burr was unable to retract over the wire.The target lesion was located in the severely calcified superficial femoral artery (sfa).A 2.00mm peripheral rotalink plus and a peripheral rotawire were selected for use.During procedure, the burr stalled on two occasions.Subsequently, upon withdrawal, it was noted that the burr could not be retracted over the rotawire.The devices were able to be removed as a single unit from the patient's body, but lost wire access wire across the lesion.A new access was obtained and successful angioplasty was performed to complete procedure.There were no patient complications reported.
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