MAUDE Adverse Event Report: COOK INC COONS INTERVENTIONAL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
The device unraveled and got stuck in the avf balloons.Per complaint form, after (b)(4) incident, the unused / unopened lot's were removed.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
On (b)(6) 2016, initial information received by the manufacturer indicated (b)(6) 2016 as the date of awareness.On (b)(6) 2016, new information was provided to the manufacturer indicating the correct date of awareness was (b)(6) 2016.(b)(4).This event is currently under investigation.
Event or Problem Description
During an avf de-clotting procedure, the device unraveled and got stuck in the avf balloons.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.Additional information was requested, however it was not provided at the time of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, manufacturing instructions, specifications and quality control 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.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
During review of the investigation of this event it was determined that the failure mode reported in mdr: 1820334-2016-00900 is a duplicate of failure modes previously reported in mdr¿s: 1820334-2016-00898, 1820334-2016-00879, and 1820334-2016-00899.

• Brand Name: COONS INTERVENTIONAL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5908189
• Report Number: 1820334-2016-00900
• Device Sequence Number: 556750
• Product Code: DXQ
• UDI-Device Identifier: 00827002026216
• UDI-Public: (01)00827002026216(17)210426(10)6859689
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/10/2019

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 Model Number: N/A
• Device Catalogue Number: THSF-35-180-COONS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 04/24/2019
• Initial Report FDA Received Date: 08/26/2016
• Supplement Report FDA Received Date: 09/07/2016; 06/13/2017; 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1