MAUDE Adverse Event Report: COOK INC HIWIRE HYDROPHILIC WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Codes	Material Fragmentation (1261); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Dyspnea (1816); Pneumonia (2011); Sepsis (2067)
Date of Event	06/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
The patient had an interventional radiology procedure done on (b)(6) 2015 involving 2 beacon tip catheters and a hiwire hydrophilic wire guide.In 2016, the patient was at another facility for a chest x-ray when it was noted that two pieces of the wire guide had fractured and remained in the patient.On (b)(6) 2016, the fragmented pieces were removed with a snare percutaneously and did not require a cutdown incision.The patient is doing very well.Event as listed on medwatch: "(b)(6) year old male admitted to angio suite at @0900 with pre-op sx.Of critical stenosis.Under mac, patient underwent percutaneous procedures as follows: transferred to pacu in stable condition.Discharged home on (b)(6) 2015.On (b)(6) 2016: patient presents to area hospital with three day history of coughing, fever dyspnea, vomiting and malaise.Patient is "septic, appears to have pneumonia".Incidental finding of retained foreign body (guidewire) noted in thoracic aorta extending up from the left groin and terminating in the aortic arch.Impression: retained foreign body ".The fragmented pieces were removed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).During the course of the investigation, a review of the complaint history, instructions for use (ifu), and trends of the product was conducted.No product was returned to assist in this investigation.The provided ifu provides directions for use, warnings, and cautions regarding proper use of this device.Specifically, it states "use of alcohol, antiseptic solutions or other solvents must be avoided, because they may adversely affect the surface of the hydrophilic wire guide." "avoid manipulating or withdrawing the hydrophilic wire guide back through a metal needle or cannula.A sharp edge may scrape the coating or shear the wire guide.A catheter, introducer sheath or vessel dilator should replace the needle as soon as the wire guide has been inserted in the vessel." based on the information provided and as the actual complaint product was not returned to assist in the investigation, a root cause cannot be determined with certainty.The appropriate personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
The patient had an interventional radiology procedure done on (b)(6) 2015 involving 2 beacon tip catheters and a hiwire hydrophilic wire guide.In 2016, the patient was at another facility for a chest x-ray when it was noted that two pieces of the wire guide had fractured and remained in the patient.On (b)(6) 2016, the fragmented pieces were removed with a snare percutaneously and did not require a cutdown incision.The patient is doing very well.Event as listed on medwatch." (b)(6) admitted to angio suite at @0900 with pre-op sx.Of critical stenosis.Under mac, patient underwent percutaneous procedures as follows: transferred to pacu in stable condition.Discharged home on (b)(6) 2015.On (b)(6) 2016: patient presents to area hospital with three day history of coughing, fever dyspnea, vomiting and malaise.Patient is "septic, appears to have pneumonia".Incidental finding of retained foreign body (guidewire) noted in thoracic aorta extending up from the left groin and terminating in the aortic arch.Impression: retained foreign body ".The fragmented pieces were removed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: HIWIRE HYDROPHILIC WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5782776
• Report Number: 1820334-2016-00578
• Device Sequence Number: 762184
• Product Code: DXQ
• UDI-Device Identifier: 00827002363007
• UDI-Public: (01)00827002363007(17)170301(10)10385576
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K000011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2016
• Report Date (Section F): 06/15/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HWA-35-260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/17/2015
• Device Age: MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 08/31/2016
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 83
• Date Report Sent to FDA: 06/15/2016