It was reported a male patient required replacement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.The catheter was initially placed in the patient during a nephrostomy exchange and connected to drainage bag.A wire guide was introduced to remove the previous catheter and a the complaint device was placed over the wire.The following day after placement, the patient returned to the facility with confirmed leaking at the catheter hub.The complaint device was removed and replaced.It should be noted, the user denied any forced exertion on the catheter and confirmed the fitting was securely attached on first inspection.No other adverse effects were reported for this incident.
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Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Additional information: e1- customer (person) information (b)(6).Investigation ¿ evaluation.It was reported by (b)(6) that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-25-p-5s-cldm-hc; lot#: 14167369) leaked.The device was required for a nephrostomy exchange to drain urine.During the procedure, a guide wire was advanced into the catheter (manufacturer, model, and lot# unknown) located in the patient¿s posterior torso.Then the old catheter was removed and the new an ultrathane dawson-mueller catheter was advanced over the guide wire and into the patient¿s kidney.The catheter was then connected to a drainage bag and later the patient left the facility.The following day the patient returned reporting bleeding and leakage from the catheter.Leakage was specifically noted at the junction of the catheter and cap as evidenced by a provided photo.As a result, the patient required an additional procedure to replace the catheter.No other adverse effects were reported for this incident.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot (14167369) and related subassembly lots revealed no relevant non-conformances.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi_rev5, multipurpose drainage catheter] states the following."unlocking catheter loop¿ note: for catheter exchange, advance the distal end of the wire guide into the locked loop configuration of the catheter before unlocking the mac-loc assembly.Release the mac-loc as described above.Advance the wire guide through the catheter end hole.Catheter exchange can now be performed.How supplied: upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no returned device, and the results of the investigation, it was concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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