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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
A male with history of prostate cancer and prostatectomy had deep vein thrombosis (dvt) of the left lower extremity.Surgeon had attempted insertion of inferior vena cava (ivc) filter with venogram.Since the left iliac vein was clotted, it was decided to go on the right side.Surgeon was able to cannulate the vein, but could not pass the wire.So, therefore, the ultrasound machine was used and it was noted that the vein was posterior to the artery.Ir recommended jugular approach.Then, the right internal jugular was tapped, through which a wire was passed.However, the surgeon could not pass the wire too far below the diaphragm, and the wire met resistance.Therefore, a venogram was done and this showed there was compete occlusion of the ivc about 3 inches below the diaphragm with collateral formation.Because of that, the sheath was removed from the neck and pressure was applied to the puncture site.The procedure was terminated and the patient was sent home.The patient returned to the emergency department (ed) later with c/o bilateral leg pain and swelling.Cta of chest showed a linear metallic foreign body within the right common femoral vein.Approx.1cm.Surgeon felt retained broken wire would not cause harm and would not travel, especially with the patient's preexisting ivc occlusion.Patient was transferred to a tertiary care facility where he had his original prostatectomy due to the presence of bilateral dvt's and complete occlusion of the ivc.The vascular surgeon at the facility did not feel surgery was indicated on this patient and refused to accept the patient.The vascular medicine doctor accepted the patient with the plan for aggressive anticoagulation therapy.
Additional Manufacturer Narrative
Product code: dqx.A review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.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.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• 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: 6092939
• Report Number: 1820334-2016-01274
• Device Sequence Number: 16522621
• Product Code: DXQ
• UDI-Device Identifier: 00827002362826
• UDI-Public: (01)00827002362826(17)160901(10)10311249
• Combination Product (Y/N): N
• PMA/510(K) Number: K000011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2017

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-35-150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Supplement Report FDA Received Date: 06/02/2017
• 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