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

Model Number	N/A
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that during an unspecified procedure using a roadrunner uniglide hydrophilic wire guide, the physician states that the coating was coming off on the stiff angled glide wire once again.At the time of this report, additional information was requested but not yet received.
Additional Manufacturer Narrative
Product code: dqx.The initial report stated that the device had not yet been received.However, the field on the initial report indicated that it had been received on (b)(6) 2017.The field was correct.Investigation - evaluation a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The roadrunner uniglide hydrophilic wire guide was returned for evaluation.The hydrophilic coating was noted to be present without damage to the wire guide.A document-based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows nine non-conformances for surface defect, which is related to this failure mode.It should be noted this is the second complaint for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use.Specific items addressed include preparation and wire guide use: there is no information from the customer regarding the handling of the device and method of reactivation of the hydrophilic coating during the procedure.Based on the information provided and results of the investigation, the most likely root cause of the reported event may be related to user technique, storage related, product handling during the procedure, and/or compatibility related; however, this cannot be determined conclusively.Per the quality engineering risk assessment ,no further action is required.We will continue to monitor for similar complaints.

• Brand Name: ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6522363
• Report Number: 1820334-2017-00823
• Device Sequence Number: 13785766
• Product Code: DXQ
• UDI-Device Identifier: 00827002305069
• UDI-Public: (01)00827002305069(17)200223(10)7696518
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K130766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HPWAS-35-260
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1