MAUDE Adverse Event Report: COOK INC HIWIRE NITINOL HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number HW-035150

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 during a percutaneous nephrolithotomy (pcnl) procedure, following need access, the hiwire nitinol hydrophilic wire guide was put through the needle cannula.The wire either was sheared or knotted when attempts were made to get down the ureter.The doctor also used a 5fr open ended catheter to attempt to change out the wire with a different version.Ultimately, they had to cut the wire to get it out.No visible piece was left and it is believed that all the wire was retrieved.Inability to get kidney access led to ureteroscopy with laser.There were no adverse effects or consequences to the patient resulting from this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, and specifications.One opened package labeled rpn hw-035150, lot 10669299 with cook manufacturing date 2016-4 and expiration date 2019-4 was received.The wire was returned along with a (020015) ureteral catheter.Both the wire guide and ureteral catheter are severed into two segments; one catheter segment was severed at the 15cm ink band.The second catheter segment has a severe accordion appearance with the wire guide lodged inside.The wire guide could not be removed.7mm of wire protruded from the severed catheter end.The wire guide was separated 23cm from the distal tip.The coating on the wire has been cut and stripped from the wire in several locations; shreds of the wire coating were bunched up around the end of the proximal catheter segment.The wire guide was sent to the supplier for additional investigation.The following information comes from the supplier's investigation.A review of the device history records did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested and was determined to be acceptable.As noted above, the specimen is firmly lodged within the longer catheter section and presents extensive bend damage of varying frequency and severity, a separation/cut 22.9cm from the distal tip (as noted in the complaint narrative) and several areas of skive damage to the polymer jacket material.The catheter tubing encasing the bulk of the specimen wire presents compressive overload along the axis of the tubing in the form of an accordion appearance which is impinging on the specimen wire, preventing its removal.The skive damage proximal of the catheter tubing appears consistent with the application of a torque device with a metal collet during the attempted removal of the wire from the catheter tubing.The skive damage in the cut location appears consistent with manipulation of the wire within the needle mentioned in the complaint narrative.As indicated in the precautions portions of the device instructions for use (dfu), when using wire guide through a metal cannula/needle, use caution as damage may occur to the outer coating.It is not possible to assign a definitive cause for the event as reported.Based on the evidence presented by the sample and the information provided by the supporting documentation, clinical and/or procedural factors appear to have impacted on the event as reported.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.With the information available the cause of this issue is unable to be determined.However, it is feasible to suggest that procedural factors may have impacted the reported issue.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Event Description

It was reported during a percutaneous nephrolithotomy (pcnl) procedure, following needle access, the hiwire nitinol hydrophilic wire guide was put through the needle cannula.The wire either was sheared or knotted when attempts were made to get down the ureter.The doctor also used a 5fr open ended catheter to attempt to change out the wire with a different version.Ultimately, they had to cut the wire to get it out.No visible piece was left and it is believed that all the wire was retrieved.Inability to get kidney access led to ureteroscopy with laser.There were no adverse effects or consequences to the patient resulting from this occurrence.

• Brand Name: HIWIRE NITINOL HYDROPHILIC WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7299067
• MDR Text Key: 101024681
• Report Number: 1820334-2018-00464
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304765
• UDI-Public: (01)00827002304765(17)190430(10)10669299
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: HW-035150
• Device Lot Number: 10669299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention