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

Model Number N/A

Device Problem Cut In Material (2454)

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

Event Date 01/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event is currently under investigation.

Event Description

Coating began to unravel from the first wire used (1820334-2016-00048).The doctor used a different wire in a different scope, upon advancing the wire, it became tight and was noted to have a nick upon removal (1820334-2016-00044).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.

Manufacturer Narrative

(b)(4).Investigation/evaluation: during the course of the investigation, a review of complaint history, documentation, instructions for use (ifu), trends and a visual inspection of returned devices were conducted.The complaint device was not returned to assist with this investigation.Two unused devices were returned.The two returned products were opened, lubricated, and removed from the wire guide holders.Using a gloved hand, the surface of the devices were evaluated.No nicks, or surface imperfections/defects were noted on the two returned products.Based on the investigation evaluation, there was no indication that a design or process related failure mode contributed to this event.The ifu states "when using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating." it is likely that this event was related to product handling as the coating was likely damaged by the access needle.There is no evidence to suggest this product was not manufactured to specifications.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

Coating began to unravel from the first wire used (1820334-2016-00048).The doctor used a different wire in a different scope, upon advancing the wire, it became tight and was noted to have a nick upon removal (1820334-2016-00044).The patient did not require and additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to 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
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5383944
• MDR Text Key: 36566243
• Report Number: 1820334-2016-00044
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HWS-035150
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/14/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2016
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/08/2016
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2015
• 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): Other