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

Catalog Number HW-035150

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The user facility reported during a port-a-cath insertion procedure, the coating of the wire came off inside of the patient.The patient was sent to interventional radiology to remove the coating; however the coating remains inside of the patient as they were not able to remove it.The patient outcome after this event has been requested; however, at this time it is unknown if the patient had any adverse effects related to this event.

Manufacturer Narrative

Investigation/evaluation: a visual inspection and dimensional verification of the returned device was conducted.A review of complaint history , device history records, instructions for use and specifications was also performed.This returned device was sent to the supplier for investigation.The supplier evaluated the device and provided the following results.The specimen consists of one-1 hydro gw std s 150-035; returned loaded within the partial dispenser assembly (less the j-straightener attachment) and single-bagged within a ¿zip-lock¿ style poly biohazard pouch.The specimen presents an overall length of 150.30cm and a finished diameter of.03135¿ to.03395¿.A gage bushing certified to be.0350¿ passed over the length of the specimen with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity.All diameter measurements were acquired with a non-contact, toolmakers scope after allowing the specimen device to become dry after hydrating the specimen device with blood-bank saline.After flushing the dispenser assembly with blood-bank saline, the specimen removed and was subjected to visual and tactile examination.The specimen coating appears visually and tactilely consistent when examined at 1x ¿ 18 inches, unaided, wet.The specimen presents cut/skive damage in a proximal to distal orientation with approximately ¼ turn rotation located 2.65 to 28.0cm from the distal tip exposing 27.85cm of core wire.Microscopically the specimen coating appears to be worn and abraded with imbedded deposits of dried blood-like material.Except where noted, the specimen device appears visually and dimensionally correct.A review of the device history records does 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.The cut/skive damage appears consistent with manipulation of the wire within a metal cannula/needle.As noted in the precautions section of the device instructions for use (dfu), when using a wire guide through a metal cannula or needle, use caution as damage may occur to outer coating.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.Based on the investigation evaluation, 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.Based on the provided information a definitive root cause cannot be established.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7123607
• MDR Text Key: 95048109
• Report Number: 1820334-2017-04193
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304765
• UDI-Public: (01)00827002304765(17)200801(10)10875187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

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 Catalogue Number: HW-035150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR