As reported on january 27, 2017 via a user medwatch mw5066785: during explant of power port, it was found to fragmented, interventional radiology consulted, pt taken to cath lab for removal of remaining catheter fragment.There was no report of patient harm or injury.It was reported defective device is available for return to the manufacturer for a device evaluation.
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As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description is not confirmed, as no sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A device history review of the packaging, port assembly and catheter tubing lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.A potential root cause for the catheter fracture may be due to "pinch off syndrome".The directions for use supplied with the device instructs the physician/clinician on how to properly implant the catheter/port, and cautions against certain handling techniques to avoid "pinch-off syndrome".The instructions for use, which is supplied to the user with this catalog number, contains the following statements: potential complications: catheter fragmentation and catheter pinch-off.Catheter placement considerations: warning: avoid medial catheter placement into subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route in the subclavian vein.Pinch-off syndrome: pinch-off syndrome signs may include difficulty in aspirating blood, resistance to flushing or infusion of medications or fluids that improves with position changes, infraclavicular pain and/or swelling with catheter flushing or infusion palpitations, sudden onset chest pain, cardiac arrhythmias, extra heart sound, chest wall swelling at the port pocket, vein insertion site, pain in shoulder or port area not associated with swelling, cough, paresthesia of arm on side of catheter withdrawal occlusion or swishing sound with catheter flushing.Warning: avoid medial catheter placement into subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route in the subclavian vein.Note: if infusion or aspiration is successful upon lifting arm above the head and turning the head, consider pinch-off syndrome as a possible cause.The line should be radiologically evaluated if pinch-off syndrome is suspected.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint reference (b)(4).
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