MAUDE Adverse Event Report: COOK INC COPE STAINLESS STEEL MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number N/A

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

510k status: preamendment.(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

The international customer reported that, during a nephrostomy procedure, the distal tip of the cope stainless steel mandril wire guide broke.The physician utilized a device from another supplier to complete the procedure with no adverse events or additional procedures necessitated stating there were no clinical consequences to the patient.The device is reportedly unavailable for return and evaluation.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was 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.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We have notified the appropriate personnel and will continue to monitor for similar events.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Additional information: h6: conclusion code: failure to follow instructions(18).H10: further review and discussion of the record prompted a reassessment of the root cause.The possible root cause of this complaint was determined to be use error.The instructions that come with the wire guide warn that manipulation of the wire through the needle or removal of the wire through the needle can cause damage to the coil.It could not be confirmed in this instance whether the guide was withdrawn through the needle.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: COPE STAINLESS STEEL MANDRIL WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7252912
• MDR Text Key: 99992012
• Report Number: 1820334-2018-00408
• Device Sequence Number: 1
• Product Code: DXQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PMG-18-60-COPE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1