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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/14/2017
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
After opening a similar device from the same lot number and finding the "j" curve to be unsatisfactory, a new device was opened and prepped for the catheterization of the left heart of an unknown patient.However, the device had a crack at the j tip and was not used.A third device was opened and the procedure was completed successfully.No adverse events have been reported regarding the complaint device.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, quality control data, dimensional verification, and a visual inspection of the returned device was conducted during the investigation.One safe-t-j fixed core wire guide was returned for investigation.Inspection of the returned device noted slight elongation of the coil at the distal end(portion of curve).Proximal and distal welds are present and secure."j" curve is 5 mm and per drawing are out of specification.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 two other complaints reported for this lot number, one of which is related to this event.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.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: SAFE-T-J FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6792924
• Report Number: 1820334-2017-02606
• Device Sequence Number: 831871
• Product Code: DQX
• UDI-Device Identifier: 00827002005419
• UDI-Public: (01)00827002005419(17)220425(10)7784421
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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: TSCF-38-145-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1