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

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during an unspecified peripheral angiogram, the roadrunner uniglide hydrophilic wire guide was not able to be advanced.When it was pulled out, the mandril was exposed and the hydrophillic coating was peeled over it.The procedure was completed successfully with another uniglide.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
Device evaluated by manufacturer.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.One roadrunner uniglide hydrophilic wire guide was returned for evaluation.Upon visual inspection the 1mm of core wire was noted to be protruding at the distal end.The wire guide length, wire guide jacket outer diameter and outer diameter proximal end of the nitinol tapered wire were all found to be within specifications.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not manufactured according to specifications.Review of device history record shows there were non-conformances related to this failure mode.However these devices were removed during production and scrapped.It should be noted that there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use.Specific items addressed include: warning: to prevent possible tissue damage, care should be taken when manipulating a device over a wire guide during the device's placement and withdrawal.If resistance is felt during device placement, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, remove the wire guide and device as a unit to prevent possible damage and/or complications.Based on the available information and the results of the investigation, a definitive root cause to the reported event could not be conclusively determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Cook will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
(b)(4).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.One used roadrunner uniglide hydrophilic wire guide was returned for investigation.1mm of core wire is protruding at the distal end.The wire guide length, wire guide jacket outer diameter and wire guide outer diameter proximal end of the nitinol tapered wire were within specifications.A section of the outer jacket was removed to measure the outer diameter of the nitinol wire.No peeling or damage was noted to the jacket during physical evaluation of the returned device.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.Per ifu, "if resistance is felt during device placement, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, remove the wire guide and device as a unit to prevent possible damage and/or complications.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." based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.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: 6561775
• Report Number: 1820334-2017-00948
• Device Sequence Number: 18972223
• Product Code: DXQ
• UDI-Device Identifier: 00827002561779
• UDI-Public: (01)00827002561779(17)200302(10)7714996
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2017

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-35-180
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: Not provided; 09/11/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 06/28/2017; 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1