The product is expected to be returned, but has not yet been received.Upon receipt and evaluation of the device a supplemental report will be submitted with the investigation findings.The correct lot number was not provided; therefore, a review of the manufacturing records could not be completed.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.(b)(4).
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Our product evaluation laboratory received one swan ganz pacing catheter.The proximal circuit was found to be open.The proximal lead wire was found to be broken approximately 2.5cm proximal of the distal tip.Insulation was not present on the lead wires at the location of damage.The distal electrode circuit was found to be continuous.The catheter body was found to be in good condition.The balloon inflated clear and concentric and did not leak.A device history record review was completed and documented that the device met all specifications upon distribution.Report of "defective pacing wire" was confirmed.An engineering evaluation task was initiated to assess manufacturing-related processes which could be correlated to the complaint.Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients.There are multiple failure modes that may require the exchange of a pacing catheter.Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter.Stretching, kinking, or forceful wiping of the catheter may result in damage.After stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration.Care should be taken not to kink the catheter body when securing it.In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported event.Correction upon receipt of the device by the product evaluation laboratory, the model number was confirmed to be d97130f5 not d98100.The correct lot number, 60789579, was supplied by the customer, but the model number was incorrect.It was confirmed that the lot number was correct after confirmation of the correct model number was received.Udi number is (b)(4).
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