|
Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): postal code: (b)(6).G4 ¿ pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional, relevant information become available.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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
|
It was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter separated.The device was required for use as a retrograde ureteric stent and was placed in the patient's left kidney/ureter area.About two weeks later, the patient experienced pain and discomfort, so they returned to the facility on either (b)(6) 2023 or (b)(6) 2023.The patient was seen by the on-call renal physician whom noted that the catheter could not be flushed.The patient was advised to return on (b)(6) 2023 to see the attending physician.On (b)(6) 2023, the patient returned to the facility.Imaging with contrast was performed and separation of the catheter about halfway between the hub and pigtail was discovered; the contrast formed a "ball" near the fractured portion of the device.The physician discussed options for retrieval with his colleagues.It was decided that the catheter would be removed with aid of a cook amplatz wire, a cook bmc catheter, a 35mm gooseneck snare, and a vascular sheath.The wire guide and catheter were inserted through the proximal lumen, past the fracture, to the distal pigtail section of the device.The portion of the catheter attached to the hub was successfully removed.The distal portion of the catheter remained in a pigtail.Using a "stitch technique to cut the flared end," the snare retracted the distal portion of the catheter inside the sheath.The pigtail was straightened during retraction and the catheter was removed.No portion of the device remained inside the patient.A new, like-device was placed in the patient.It was noted that the patient and the patient's wife were accustomed to flushing the catheter at home.It was also noted that based on the damage to the catheter, the physician suspects the catheter may have been occluded prior to separation.No other adverse effects were reported for this incident.
|
|
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.A representative from the nhs supply chain (great britain) reported that an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-45-p-6s-clm-rh; lot#: 15110420) separated.The device was required for use as a ureteric stent.Access was gained through the patient¿s left middle back, and the device was placed in the patient's left kidney/ureter area.About two weeks later, the patient experienced pain and discomfort, so they returned to the facility on either 15apr2023 or 16apr2023.The patient was seen by the on-call renal physician who noted that the catheter could not be flushed.The patient was advised to return on 17apr2023 to see the attending physician.On 17apr2023, the patient returned to the facility.Imaging with contrast was performed which confirmed separation of the catheter shaft inside the patient.The separation was observed about halfway between the hub and pigtail.The physician discussed options for retrieval with his colleagues, and a procedure was performed to successfully remove and replace the catheter.No portion of the device remained inside the patient.No other adverse effects were reported for this incident.It was noted that the patient and the patient's wife were accustomed to flushing the catheter at home.It was also noted that based on the damage to the catheter, the physician suspects the catheter may have been occluded prior to separation.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.The customer returned the ult10.2-38-45-p-6s-clm-rh, ultrathane mac-loc locking loop multipurpose drainage catheter, lot 15110420 in three sections, with the presence of dried biological matter.The 2nd section of the catheter shaft, at the distal end exhibited ballooning of the catheter material.The catheter passed the gap gauge requirement.Additionally, 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.Cook also reviewed the device history record (dhr).The dhrs for lot 15110420 and related subassembly lots record no relevant non-conformances.It should also be noted that there were no additional complaints found for this lot.Cook reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_mult2i_rev1, multipurpose drainage catheter] states the following.Precautions -patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter." how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the dmr, ifu, dhr, and returned device suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook medical has determined the root cause category would fall under cause traced to component failure without any design or manufacturing issue.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.
|
