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

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product code: dqx.Occupation: lead technician.Initial reporter also sent report to fda: unknown.Pma/510(k) #: preamendment.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
It was reported a coons interventional wire guide was used in an unknown patient for abscess drainage procedure.As reported, "the wire guide was introduced through a quick core biopsy needle.They tried to remove the wire guide through the needle and the tip of the needle sheered the wire guide.¿ at this point, no intervention has been performed.An unknown amount of the wire guide remained inside the patient.No additional procedures have been performed at the time of this report.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
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
Additional information: investigation ¿ evaluation a review of the complaint history, device history record, manufacturing instructions, and quality control 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.A review of the device history record showed one related nonconformance, but all nonconforming product was scrapped and quality control procedures were performed on all devices in the lot.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no returned product, and the results of the investigation, the root cause was determined to be "unintended use error." the customer stated the wire guide was withdrawn through a needle.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.

• 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: 8407667
• Report Number: 1820334-2019-00617
• Device Sequence Number: 13947000
• Product Code: DQX
• UDI-Device Identifier: 00827002023567
• UDI-Public: (01)00827002023567(17)210727(10)7116300
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2021
• Device Model Number: N/A
• Device Catalogue Number: THSF-35-145-COONS
• Device Lot Number: 7116300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other