COOK INC COOK SPECTRUM; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter.Initial reporter customer (person), phone number:(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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It was discovered upon device return that the catheters of a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter had occluded.It was initially reported that the wire guide was difficult to remove from the device as it was withdrawn following catheter placement in the subclavian vein.The physician removed both the wire and catheter together and opened a new device for an attempted second placement.The same issue with difficult wire removal occurred with the new device.A third device was opened to successfully complete the procedure.It was later reported that imaging guidance was used to place the catheter, and no resistance was felt when advancing the wire guide.During placement, the distal tip of the wire was always leading the distal tip of the catheter.Upon return of the two complaint devices to the manufacturer, it was discovered that both catheters were occluded.One separated wire guide was also found and is referenced in the report with patient identifier: (b)(6).
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Event Description
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No new patient and/or event information.
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Manufacturer Narrative
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Correction: this report is being sent to indicate the complaint event is not reportable.Upon further investigation, this event is not reportable.This report was submitted based on the condition of returned devices for a complaint on difficulty removing a wire from the catheter.The user reported no difficulty advancing the wire through the catheter.It was determined that the likely cause of the occlusion was biomatter during transit to the manufacturer.The occluded condition of the returned device was expected due to its used condition.As there is no communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device and the status of the returned device was expected due to its used condition, this does not meet the definition of a complaint or reportable event.
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