Catalog Number 1008197-20 |
Device Problems
Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device has not yet been received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a non-tortuous, mildly calcified iliac artery.A 6.0x20mm viatrac balloon dilatation catheter failed to advance on a 0.014 guide wire (gw) as it met resistance with the gw and got stuck.The device was removed and it was noted that the tip was damaged.No patient effects.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Device codes: 2017 labeled.Internal file number - (b)(4).Corrections: device status changed from returning to not returned.Device code 2017-excessive force.The device was not returned for analysis.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 of the reported lot revealed no other incidents.It should be noted that the viatrac plus instruction for use states: if resistance is met during manipulation, determine the cause of the resistance before proceeding.The investigation was unable to determine a cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Event Description
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Correction to case details: the physician applied excessive force to try to advance the balloon over the wire.No additional information was provided.
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Search Alerts/Recalls
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