MAUDE Adverse Event Report: COOK INC HEAVY DUTY FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G01057
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.Occupation = non-healthcare professional.Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As initially reported, during an unknown procedure, a heavy duty fixed core wire guide became stuck in the drainage catheter.The procedure was completed and a new drain was placed.Upon return and examination of the device on 02apr2019, however, the manufacturer observed the wire guide to be unraveled and elongated.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation reviews of the manufacturing instructions, complaint history, device history record, documentation, drawing, and quality control, as well as a visual inspection of the returned device were conducted during the investigation.On visual inspection of the device, the device was lodged in a ult catheter, with biomatter present on both devices.Coil elongation of the device was confirmed.No separation was observed.The wire guide was unable to be removed from the catheter without separation and was thus removed via separation from the proximal end of the catheter.Additionally, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, the complaint has been confirmed based on customer testimony and inspection of the returned device.Investigation has concluded no evidence to suggest that the device was not manufactured to specification.Investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.

• Brand Name: HEAVY DUTY FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8487219
• Report Number: 1820334-2019-00800
• Device Sequence Number: 11243233
• Product Code: DQX
• UDI-Device Identifier: 00827002010574
• UDI-Public: (01)00827002010574(17)230918(10)9156795
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2023
• Device Model Number: G01057
• Device Catalogue Number: THSF-35-145
• Device Lot Number: 9156795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1