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

Catalog Number	HW-038150
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that while using a two part trocar needle as a cannula for the hiwire nitinol hydrophilic wire guide, the wire guide was left inside of the patient's right kidney, approximately 10cm during a percutaneous nephrolithotomy (pcnl).The urologist removed the wire by using an amplatz introducer.The user also stated that the two part trocar needle was not smooth on the inner side.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence. according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, quality control data and specifications.The supplier of the component reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 10966115.The history records indicate this product was final inspection tested and determined to be acceptable.A review of complaint history revealed no other complaints have been received on the same lot.As noted in the precautions section of the device instructions for use (ifu), when using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.The question of what exactly ¿shredding¿ consisted of was unable to be answered, as the customer was unable to be reached for clarification on this description.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.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 or Problem Description
No additional event information has been received since the last report filing on 25may2018.
Additional Manufacturer Narrative
Concomitant products: karl storz endoscope, two part needle, amplatz renal introducer.

• Brand Name: HIWIRE NITINOL HYDROPHILIC WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7459135
• Report Number: 1820334-2018-00973
• Device Sequence Number: 1092347
• Product Code: OCY
• UDI-Device Identifier: 00827002304734
• UDI-Public: (01)00827002304734(17)210214(10)10966115
• Combination Product (Y/N): N
• Initial Reporter Country: MN
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2021
• Device Catalogue Number: HW-038150
• Device Lot Number: 10966115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 05/08/2018; 08/03/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/25/2018; 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 115