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	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during a procedure, the tip of the safe-t-j rosen catheter exchange wire guide was about to snap off.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
It was later clarified by the customer in a response to a request for additional information that the physician noticed that the tip of the wire was about to snap off prior to patient contact.Another wire guide was used to complete the procedure.This event is currently under investigation.A supplemental report will be provided upon conclusion.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that there was a 1 mm separation which was noticed at a distance of 7 mm from the distal tip 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, the root cause was determined to be related to the manner in which the product was shipped.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• 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: 7140402
• Report Number: 1820334-2017-04488
• Device Sequence Number: 16430188
• Product Code: DQX
• UDI-Device Identifier: 00827002012530
• UDI-Public: (01)00827002012530(17)220925(10)8143709
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2018

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: 12/13/2017
• Supplement Date Received by Manufacturer: 01/03/2018; 04/23/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/10/2018; 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1