There was no product returned for this complaint.No returned product evaluation could be completed.The lot number reported was incorrect, therefore, no record review could be completed.Based on the lack of information received we cannot determine a root cause.A follow-up report will be submitted if information and / or product is returned for investigation.
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Investigation details: a manufacturing record review was completed and there were no nonconformances related to this lot therefore supporting the device met material, assembly and performance specifications prior to shipment.One unit of turnpike spiral was returned to vsi/teleflex for investigation.Minor blood particulates were found on the hub of the catheter.The catheter was decontaminated using a germicide and further inspected.About 0.6cm of the turnpike spiral was sheared off from the distal end of the catheter.No other damage was found along the length of the catheter.The following specifications were measured using a ruler and snap gauge: o.D.At the spiral tip, o.D.At the distal tip, o.D.At the proximal section.Catheter and o.D met specifications.No other damage was found on the catheter.The damage to the tip could have most likely occurred due to misuse of the catheter.As per ifu, two warnings are stated: never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury.Do not rotate the catheter more than two (2) consecutive 360° rotations in either direction if the distal tip becomes lodged and is not also rotating, as it may result in separation of the catheter, damage to the catheter, or vessel injury.If using the turnpike spiral or turnpike gold, rotate the catheter in the counterclockwise direction with backward tension in order to dislodge the tip.The account was inquired on questions related to over torqueing of the catheter, any resistance experienced, and concomitant devices used by the physician.No response was received.Based on the information and returned product evaluation, the most likely root cause of the issue is operational context and/or unintended use error.Based on the information and returned product evaluation, the most likely root cause of the issue was operational context and/or unintended use error.
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