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

Model Number N/A

Device Problem Flaked (1246)

Patient Problem No Code Available (3191)

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

The coating from the wire stripped off during a pcnl procedure.The wire was inside the patient when it stripped.The physician confirm that nothing remained inside the patients body and the coating was removed from the patient's body.It is believed the coating fragments were removed with graspers.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Phone # not provided by reporter.(b)(4).Investigation / evaluation: during the course of investigation, a review of the complaint history, instructions for use (ifu) and a visual inspection of the returned used product was conducted.A review of the lot records and manufacturing documents found them to be complete and accurate.An instructions for use (ifu) is provided with this product.The precautions section of the device instructions for use state: "manipulation of wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access.When using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating." based on the evidence presented by the sample and the information provided by the supporting documentation, it appears that procedural and/or clinical factors have impacted on the event as reported.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.Per the risk assessment no further action is required.

Event Description

During a pcnl procedure, while the wire guide was within the patient, the coating from the wire stripped off.It is believed the coating fragments were removed with graspers.The physician confirmed that the coating was entirely removed from the body of the patient.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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5010402
• MDR Text Key: 23257850
• Report Number: 1820334-2015-00526
• Device Sequence Number: 1
• Product Code: OCY
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/27/2015

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: HWA-035150
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2015
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• 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