It was reported that the port was implanted via right internal jugular vein.The blood return and flush could be confirmed.However, thirteen months post procedure, a subcutaneous hematoma was allegedly found along the tunnel of the catheter, therefore the port system was removed.The subcutaneous hematoma was treated by plastic surgery.There was no reported patient injury.
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Manufacturing review: a lot history review, a dhr review, and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: one titanium lp port, one cath-lock, and one 8fr groshong catheter was returned for evaluation.Visual, microscopic, functional, and tactual evaluations were performed.The investigation is confirmed for catheter leakage, more specifically, flexural fatigue damage.A straight, circumferential split was observed approximately 0.75 cm distal to the cath-lock and a t-shaped split was observed approximately 7.5cm distal to the cath-lock.A brownish piece of material encircled the catheter, which had the appearance of biological material, with what appeared to be a suture on the inside.Five photos were also returned for evaluation and the photo review results are consistent with the evaluation of the physical sample.In addition, kinks were observed around the distal split, in which region what appeared to be a suture, within biological residue, was found around the catheter.The identified splits are typical of flexural fatigue, which is the repetitive, cyclic kinking of the catheter.Such kinking may have physiological, placement, usage or mechanical contributing factors.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.However, the catheter appears to have a suture near several of the kinks/breaks in the catheter.
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