Our product evaluation lab received one model number 12tlw803f catheter without any attached components.The balloon was found to be ruptured.A closer examination found no deterioration was on the latex.After cutting the distal windings, it was unable to determine if edges matched up.Per the ifu, balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures.To minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume and pull force for each size catheter.No visible damage or inconsistency was observed from catheter body and windings.Thru-lumen was patent without any leakage or occlusion.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
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It was reported that the balloon of model 12tlw803f fogarty catheter from lot 64394458 did not inflate during the inflation test before use in the patient.The issue was resolved by replacing the device with a new one.There were no patient complications reported.Per the product evaluation findings, the balloon ruptured, however it was unable to determine if the edges matched up.There was no deterioration found.
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