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

Model Number N/A

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem No Code Available (3191)

Event Date 06/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.This event is currently under investigation.

Event Description

The device unraveled and got stuck in the avf balloons.Per complaint form, after 5th incident, the unused / unopened lots were removed.A section of the device did not remain inside the patient's body.

Manufacturer Narrative

On 09aug2016, initial information received by the manufacturer indicated 03aug2016 as the date of awareness.On 25aug2016, new information was provided to the manufacturer indicating the correct date of awareness was 25july2016.This event is currently under investigation.

Event Description

Initial information provided states: the device unraveled and got stuck in the avf balloons.Per complaint form, after 5th incident, the unused / unopened lots were removed.A section of the device did not remain inside the patient's body.Additional information provided indicated the following: the physician had a very detrimental product(s) failure associated with the coons interventional wire guide.He experienced three wire failures of varying lot numbers in the same procedure on the same patient.This required an extended stay in icu as well as failure of a previously patent avf for dialysis.Initially one of the wires got stuck in a diagnostic catheter (1820334-2016-00898), after removing all products with the exception of the sheath, wire access was gained again across the lesion.Upon deflating the pta balloon catheter it was noted the catheter was stuck on yet again another coon's wire (1820334-2016-00899).This particular incident was critical as the subclavian a.Had ruptured; had the pta catheter not gotten stuck, wire access across the rupture would have made placing a covered stent graft easier thus saving the avf.Instead, once again, everything aside from the sheath had to be removed and wire access across the lesion had to be acquired in order to place a covered stent graft to save the subclavian a.And prevent the patient from having to have an open procedure in order to save the arm.A temporary dialysis access catheter had to be placed as the avf was no longer usable.Additional information was requested, however it was not provided at the time of this report.

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.

• Brand Name: COONS INTERVENTIONAL WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5910769
• MDR Text Key: 53384941
• Report Number: 1820334-2016-00899
• Device Sequence Number: 1
• Product Code: DXQ
• UDI-Device Identifier: 00827002026216
• UDI-Public: (01)00827002026216(17)210426(10)6859689
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: THSF-35-180-COONS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2017
• Date Device Manufactured: 04/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention