MAUDE Adverse Event Report: COOK INC STANDARD FIXED CORE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number 638413

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: patient care manager.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, during an ureteral dilation procedure using a standard fixed core wire guide the guide wire broke in half.The wire did not break in the patient, but rather upon removal.It was on the sterile tray, and when it was moved to be disposed of in the "sharps bin the one end twisted like on an elastic".The employee handling the device at this point had the skin on their finger punctured.It is noted that this is one of two wires to break this way.(reference patient identifier (b)(6)).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.

Event Description

No new patient or event information has been reported since the last report was submitted on 07aug2019.

Manufacturer Narrative

Corrected information: d10 (concomitant medical products).Investigation/evaluation: reviews of the complaint history, manufacturing instructions, specifications, and quality control data were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Due to the lack of information from the user facility, the lot number of the device is not known; accordingly, a review of the device history record could not be conducted.A search for complaints on the same lot could not be performed.With the known information, there is no evidence to suggest there is nonconforming product in house or out in the field.There is no instructions for use (ifu) packaged with this device for review.The complaint device was not returned for investigation and no images or videos were provided, so a failure analysis could not be performed.The information provided upon review of the manufacturing documents, suggest that there is no evidence the device was not manufactured to specification, or that there are nonconforming devices in house or out in the field.The complaint was confirmed based on customer testimony.It was concluded that component failure without design or manufacturing issue contributed to the failure mode.It is possible that compatibility issues occurred with components used during the procedure.It is also possible that the wire became damaged upon insertion to the patient, during manipulation, or upon removal.This could have been due to excessive forces, or from tortuous patient anatomy.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: STANDARD FIXED CORE WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8872014
• MDR Text Key: 154006364
• Report Number: 1820334-2019-01957
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 638413
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1