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

Catalog Number	HPWA-35-260
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.(b)(4).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
It was reported that during a training course for a difficult inferior vena cava (ivc) filter removal using a pig, the loop wire technique was used to reverse the roadrunner uniglide hydrophilic wire guide through the body of the ivc filter.The wire guide was externalized and while controlling both ends of the wire, tension was applied as the sheath was driven down over the wire to retrieve the filter.The wire guide then snapped in half.As both ends of the wire were externalized, there was no need for retrieval of the wire.The access site utilized was the right internal jugular; the pig's anatomy was not calcified or tortuous.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
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the wire guide was separated into two segments.The segments were measured to be 172.0 cm (proximal) and 88.2 cm (distal) in length.No damage was noted to the proximal segment, except for exposed core wire at the distal end of the device.The distal segment had a 1 mm cut at a distance of 71.2 cm from the proximal end, where the core wire was observed to be exposed.Kinks were noted at distances of 84.5 cm, 84.9 cm, and 85.8 cm from the proximal end of the distal segment of the device.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• 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: 7282702
• Report Number: 1820334-2018-00450
• Device Sequence Number: 16642730
• Product Code: DQX
• UDI-Device Identifier: 00827002304925
• UDI-Public: (01)00827002304925(17)200906(10)8193972
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/15/2018

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 Catalogue Number: HPWA-35-260
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1