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Model Number N/A |
Device Problems
Difficult to Remove (1528); Unraveled Material (1664)
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Patient Problem
No Code Available (3191)
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Event Date 06/23/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This event is currently under investigation.
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Event Description
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The device unraveled and got stuck in the avf balloons.Per complaint form, after 5th incident, the unused / unopened lots were removed.A section of the device did not remain inside the patient's body.
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Manufacturer Narrative
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On (b)(6) 2016, initial information received by the manufacturer indicated (b)(6) 2016 as the date of awareness.On (b)(6) 2016, new information was provided to the manufacturer indicating the correct date of awareness was (b)(6) 2016.(b)(4).This event is currently under investigation.
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Event Description
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Initial information provided states: the device unraveled and got stuck in the avf balloons.Per complaint form, after (b)(4) incident, the unused / unopened lots were removed.A section of the device did not remain inside the patient's body.Additional information provided indicated the following: the physician had a very detrimental product(s) failure associated with the coons interventional wire guide.He experienced three wire failures of varying lot numbers in the same procedure on the same patient.This required an extended stay in icu as well as failure of a previously patent avf for dialysis.Initially one of the wires got stuck in a diagnostic catheter (1820334-2016-00898), after removing all products with the exception of the sheath, wire access was gained again across the lesion.Upon deflating the pta balloon catheter it was noted the catheter was stuck on yet again another coon's wire (1820334-2016-00899).This particular incident was critical as the subclavian a.Had ruptured; had the pta catheter not gotten stuck, wire access across the rupture would have made placing a covered stent graft easier thus saving the avf.Instead, once again, everything aside from the sheath had to be removed and wire access across the lesion had to be acquired in order to place a covered stent graft to save the subclavian a.And prevent the patient from having to have an open procedure in order to save the arm.A temporary dialysis access catheter had to be placed as the avf was no longer usable.Additional information was requested, however it was not provided at the time of this report.
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Manufacturer Narrative
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Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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Search Alerts/Recalls
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