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

Model Number	G30506
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the initial reporter, it is unknown if the device will be returned.Common name & product code = dqx wire, guide, catheter.Occupation = non-healthcare professional.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an interventional procedure of the superficial femoral artery, the hydrophilic coating started to separate from a roadrunner uniglide hydrophilic wire guide.The physician removed the wire and replaced it with another cook wire.Nothing was left in the patient and no additional procedures were necessary.Additional information regarding event details has been requested, but is not available at this time.
Additional Manufacturer Narrative
Initial report: as reported, during an interventional procedure of the superficial femoral artery, the hydrophilic coating started to separate from a roadrunner uniglide hydrophilic wire guide.The physician removed the wire and replaced it with another cook wire.Nothing was left in the patient and no additional procedures were necessary.Investigation - evaluation.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device history record did record two nonconforming events which could contribute to this failure mode.All affected units were identified , however, and were scrapped prior to the final quality control check.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.The available information provides objective evidence to support that the device was manufactured to specification.An ifu is provided with this device, which states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided and no product returned, investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 9271615
• Report Number: 1820334-2019-02755
• Device Sequence Number: 2436453
• Product Code: DQX
• UDI-Device Identifier: 00827002305069
• UDI-Public: (01)00827002305069(17)220610(10)9766686
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K130766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

1 Device 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 Expiration Date: 06/10/2022
• Device Model Number: G30506
• Device Catalogue Number: HPWAS-35-260
• Device Lot Number: 9766686
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No