MAUDE Adverse Event Report: COOK INC ROAD RUNNER THE FIRM CONNORS MODIFICATION HYDROPHILIC WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
During the use of the wire, the physician was not able to advance catheter over the wire at a certain point.Physician tried two other types of catheters and realized it was the wire that was the problem.He removed wire and noticed that the hydrophilic coating had bunched up on the wire preventing the catheter from advancing over the wire.This is the second incident with this g12760.The physician used a competitors wire to complete the procedure.No injury to the patient, but led to extra procedure time and the use of extra products.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
(b)(4).Investigation - evaluation a review of the complaint history, drawings, manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported confirmed that the proximal end of the polymer jacket material to have accordioned, resulting in the increase of the od, thus preventing the wire from being removed through the catheter.Additional unopened devices were examined and confirmed that the proximal end of the jacket material was adequately heated onto the mandril wire.Since the junction site of each wire is gauged 100% for correct o.D.It is feasible to suggest that tortuous anatomy and or compatibility of the catheter made have contributed to the customers difficulty.No nonconforming events which could contribute to this failure were found.There is no evidence to suggest the product was not made to specifications.Based on the evidence displayed regarding the used and unused devices that were returned, it is feasible to conclude that patient condition and/or anatomy or possibly product compatibility regarding the catheter contributed to the difficulty.Based on the information provided 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 the use of the wire, the physician was not able to advance catheter over the wire at a certain point.Physician tried two other types of catheters and realized it was the wire that was the problem.He removed wire and noticed that the hydrophilic coating had bunched up on the wire preventing the catheter from advancing over the wire.This is the second incident with this g12760.The physician used a competitors wire to complete the procedure.No injury to the patient, but led to extra procedure time and the use of extra products.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.

• Brand Name: ROAD RUNNER THE FIRM CONNORS MODIFICATION HYDROPHILIC WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5910065
• Report Number: 1820334-2016-00866
• Device Sequence Number: 18933572
• Product Code: DXQ
• UDI-Device Identifier: 00827002127609
• UDI-Public: (01)00827002127609(17)190718(10)7109411
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K901899
• 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
• Report Date (Section B): 08/04/2016

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: RPC-35-260-CONNORS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2016
• Supplement Report FDA Received Date: 10/27/2016
• 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: Other