As reported, the gold marker bands on a 5f 110cm 6 side-hole super torque 20 marker band (mb) diagnostic catheter were very loose on the shaft of the device.Marker band movement was observed prior to/during measurement; however, all marker bands remained on the catheter.There were no reported injuries to the patient.This was during an endovascular aneurysm repair (evar) procedure.The super torque mb catheter was not jailed during the procedure.The device was stored and prepped per the instructions for use (ifu) and all marker bands were present and in their manufactured position when the device was opened and prepped.The device will be returned for evaluation.
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Complaint conclusion: as reported, the gold marker bands on a 5f 110cm 6 side-hole super torque 20 marker band (mb) diagnostic catheter were very loose on the shaft of the device.Marker band movement was observed prior to/during measurement however, all marker bands remained on the catheter.There were no reported injuries to the patient.This was during an endovascular aneurysm repair (evar) procedure.The super torque mb catheter was not jailed during the procedure.The device was stored and prepped per the instructions for use (ifu), all marker bands were present and in their manufactured position when the device was opened and prepped.One non sterile cath mb 5f pig 110cm 6sh was received for analysis.During visual analysis, marker bands 1,2,3,6,8,9 were observed to be displaced from the expected manufacturing position.All 20 marker bands were present on the catheter body.(the position of the marker bands is numerated from the proximal portion to the distal end).Inner diameter (id) and outer diameter (od) measurements were taken in the area located between the assigned places for markers bands that are offset/out of position and were found out of specification.This condition was due to the out of position marker bands compressing the body, which has the internal and outside diameter remaining in a reduced state.Longitudinal measurements were found above the expected parameters, which presented evidence of elongations.A high magnification analysis to the surface of the marker bands did not present evidence of damage (scratches, peelings, abrasions, etc.).The reported ¿marker band (supertorque mb) ¿ offset/out of position - prior to/during measurment¿ was confirmed.The catheter elongation resulted in id/od reduction and subsequent marker band migration.While the exact cause of the elongation is unknown, excessive manipulation of the catheter while the device was trapped in the patient¿s vasculature may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿contraindications: do not use the super torque mb catheter in procedures where entrapment of the catheter between endovascular devices and the vessel wall may occur, for example endovascular aortic repair (evar) procedures.Manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
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