Catalog Number B1090-040 |
Device Problems
Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 06/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Na.
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Event Description
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It was reported that during a balloon angioplasty procedure to treat a heavily calcified and non-tortuous lesion in an unspecified vessel.A 9.0x40mm armada balloon dilatation catheter (bdc) ruptured during the first inflation at 11 atmospheres.The balloon and tip separated from the shaft when attempted to be pulled back into the sheath.One of the radiopaque markers came out of the sheath when flushed out; however, the tip could not be located.It is unknown if the tip is lodged in the sheath or if it is inside the patient, the rest of the bdc was removed from the anatomy.A new sheath was inserted and another unspecified balloon was used to complete the procedure.Pedal pulses were checked and pulses were palpable.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
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Manufacturer Narrative
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Visual analysis was performed on the returned device.The reported balloon rupture and separation was confirmed.The difficulty removing was not tested due to the condition of the device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the balloon interacted with the heavy lesion calcification causing damage to the outer surface of the balloon material which subsequently ruptured during inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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