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

Model Number	N/A
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
It was reported that the physician advanced the wire through the introducer, the roadrunner uniglide hydrophilic wire guide didn't navigate as well.It was stated that once the physician removed the wire guide, he noted that the ¿wire was naked¿, as in the coating of the wire peeled off.No fragments were left inside the patient, the patient remained unharmed.No additional details have been received.
Additional Manufacturer Narrative
Common name: dqx wire, guide, catheter.(b)(4).This event is currently under investigation.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One roadrunner uniglide hydrophilic wire guide was returned in a used condition.Its length is 180.0 cm.Coating is attached but stripped off the coil from 167.5 cm to 172.8 cm from the proximal end.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.There were no other reported complaints for this lot number.Ifu¿s guide the end user on how to prevent damaging the wire surface while in use.It is possible that the wire guide met with resistance while inserting into the terumo introducer, which could have contributed to the coating peeling off the coil.However, based on the information provided and the results of our investigation; a definitive root cause could not conclusively be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed 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: 6353111
• Report Number: 1820334-2017-00284
• Device Sequence Number: 13847388
• Product Code: DXQ
• UDI-Device Identifier: 00827002561748
• UDI-Public: (01)00827002561748(17)191031(10)7397011
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2017

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: HPWA-35-180
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 04/04/2017; 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1