MAUDE Adverse Event Report: COOK INC STANDARD FIXED CORE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number 635497

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported on 18 may2020 by the attending physician, that during a cystoscopy, bilateral ureteroscopy, holmium laser lithotripsy, bilateral ureteral stent placement for treatment of bilateral kidney stones on (b)(6) 2020, the procedure was started on the right kidney, and this was completed.Upon starting on the left kidney, two cook bentson standard fixed core wire guides were placed up the left collecting system in standard fashion.The physician then advanced a flexible ureteroscope on one of the wires, but it (the ureteroscope) could not be advanced past the proximal ureter.The physician then decided to remove one of the wires in order to advance the ureteroscope.While pulling back on one wire, resistance was felt.The physician noticed that the inner component of the wire had broken, while the outer component was unravelling in the area of the urethra.The physician decided to leave everything in place and advance the cystoscope.The wire appeared to be more intact "more proximally" when it entered the left ureter.The physician then took a flexible grasper and removed the remainder of the wire guide down and out from the body.After removing the wire guide, the physician examined it and searched for any fragments that might have been left in the body with the cystoscope, but none were found.The physician then completed a retrograde ureterogram and found that the left collecting duct was intact.Further manipulation was postponed.The procedure was completed by placing bilateral ureteral stents and a urethral catheter.On 21may2020, a phone call was placed to the cook area rep to inquire about complaint device return and if the deferred left kidney procedure had been completed or rescheduled.At the time of the call, that information was not known by the cook area rep.The cook area rep did however advise at that time that the customer (physician) had told her that the patient was fine and that there were no adverse events as a result of this product issue.On 22may2020 the cook area rep sent an email response that upon follow-up with the attending physician, it was reported that the unfortunately the patient had become deceased prior to returning for completion of the left kidney procedure.The patient had developed urosepsis an unspecified time frame after the original procedure.Additional details regarding the patient and event were requested.Information requested included patient demographics, past medical history,/co-morbidities, challenges with the patient's anatomy, pre-operative lab results (including urinalysis), prophylactic antibiotics given, and timeline for all events leading to the patient becoming deceased.On 29may2020, the customer (physician) responded that they were unable to provide any additional details regarding the patient or events due to patient privacy.

Manufacturer Narrative

Investigation ¿ evaluation: description of event: it was reported, during a during a cystoscopy, bilateral ureteroscopy, holmium laser lithotripsy, bilateral ureteral stent placement for treatment of bilateral kidney stones, the procedure was started on the right kidney, and this was completed.Upon starting on the left kidney, two cook bentson standard fixed core wire guides were placed up the left collecting system in standard fashion.The physician then advanced a flexible ureteroscope on one of the wires, but the ureteroscope could not be advanced past the proximal ureter.The physician then decided to remove one of the wires in order to advance the ureteroscope.While pulling back on one wire, resistance was felt.The physician noticed that the inner component of the wire had broken, while the outer component was unravelling in the area of the urethra.Based on reported information, the patient had no adverse events related to the alleged product malfunction.This was further verified with the diagnostic imaging performed at the time of the procedure that showed all device fragments had been removed, and the collecting duct was intact.Later, it was reported that the patient had become deceased prior to returning for completion of the left kidney procedure.The patient had developed urosepsis during an unspecified time frame after the original procedure.Additional details regarding the patient and event were requested.However, no clear sequence of events/timeline has been provided.Repeated attempts to obtain information to better understand this situation have been unsuccessful.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of drawing, manufacturing instructions, and quality control data.One wire guide was returned for investigation.Physical examination of the returned device showed one wire guide was returned with biomatter present.There was a kink at 2.1cm from the distal tip.There were three kinks located at the proximal end of the wire.The weld connection from the safety wire broke, resulting in coil elongation with both the safety and mandril wire exposed.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of relevant manufacturing documents was conducted.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of relevant manufacturing documents and the returned device, suggest no evidence the device was manufactured out of specification, or that there are nonconforming devices in house or out in the field.Repeated attempts to obtain information to better understand this situation have been unsuccessful.No information was provided about the patient demographics (age, weight, height, gender), or pertinent pre-existing conditions/co-morbidities (other than bilateral kidney stones).It is not known how long after the procedure that the patient developed sepsis and died.No information was provided regarding whether prophylactic antibiotics were administered pre-operatively, intra-operatively or post-operatively.No information was provided regarding if pre-op urinalysis was performed to verify that the patient was infection free before starting the procedure.The information received supports that the patient¿s urosepsis and resulting death are not related to the alleged product malfunction.It is possible there were challenges with the patient¿s anatomy (narrowing of the upj) or user technique (exerting tension when resistance was met enough to separate the device).The investigation conclusion for this complaint is cause traced to a component failure without a manufacturing or design deficiency.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

On 29may2020, we requested if it was the attending physician's opinion that the product malfunction caused or contributed to the patient's urosepsis and / or resulting death.After multiple attempts to try an obtain an answer from the physician, as well as the urology coordinator, on 23jul2020 they advised, they did not wish to answer this question.

• Brand Name: STANDARD FIXED CORE WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10140483
• MDR Text Key: 198143702
• Report Number: 1820334-2020-01111
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 635497
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1