MAUDE Adverse Event Report: COOK INC SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G01253
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/20/2018
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 a hair was visualized inside the package of the unopened safe-t-j rosen catheter exchange wire guide.The device was not used.There was no patient involvement.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a black, hair like fiber inside sealed package.The fiber was measured to be 3.9 cm in length.Additionally, a document based investigation evaluation was performed.A review of the device history record showed the lot was released meeting all finished goods release criteria.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, the root cause was determined to be related to the device manufacturing process.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
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: SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7502492
• Report Number: 1820334-2018-01359
• Device Sequence Number: 19146048
• Product Code: DQX
• UDI-Device Identifier: 00827002012530
• UDI-Public: (01)00827002012530(17)221213(10)8398537
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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 Model Number: G01253
• Device Catalogue Number: THSCF-35-260-1.5-ROSEN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1