MAUDE Adverse Event Report: COOK INC UNKNOWN; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number UNKNOWN

Device Problems Material Separation (1562); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

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 that a female patient had a small piece of an amplatz superstiff guidewire shear off in her kidney during a percutaneous procedure.The doctor is not sure if it is the ptfe coating or a small piece of the stainless-steel core that sheared off.As reported, the patient wants to get an mri for her shoulder, so the customer inquired if the amplatz wire is ferromagnetic.The customer has advised that the guidewire is ¿long gone.¿ multiple attempts have been made to obtain additional patient, device and event information.No information has been forthcoming at the time of this report.

Manufacturer Narrative

Investigation/evaluation: the product was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A documentation based investigation was performed.This included a review of manufacturing instructions, quality control data, and specifications.The device history record could not be reviewed due to the rpn and lot number of the device being unknown.A review of complaint history was not able to be completed due to the rpn and lot number being unknown.The root cause of this failure is unknown.Possible causes of this failure include improper manipulation of the wire guide or the wire guide being withdrawn from a needle, however without the device or additional information the root cause could not be determined.Based on the information provided and the results of our investigation; potential root cause is user technique due to removal of the wire guide through the needle.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: UNKNOWN
• 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: 7286164
• MDR Text Key: 100577916
• Report Number: 1820334-2018-00469
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 03/28/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other