MAUDE Adverse Event Report: COOK INC STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G00362
Medical Device Problem Codes	Crack (1135); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that upon opening the straight and curved double flexible tipped wire guide onto the procedure trolley, it was noticed that the j tip was missing.The user attempted to fashion a j on the wire guide; however, the wire did not handle as anticipated as the outer layer cracked revealing a sharp metal from the inner layer.The wire guide was discarded and did not come into contact with a patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation : a review of the complaint history, drawings, dimensional verification, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.Straight and curved double flexible tipped wire guide was returned and examined.The core wire protrusion was 1mm in length and noted at 3.5cm from the distal end.The distal weld was cut to confirm core wire and safety wire.The device length and outer diameter was within specifications.In the devices returned condition, the wire guides curved configuration was out of specification.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record shows no nonconforming events.There were no other reported complaints for this lot number.The customer stated that the outer layer cracking occurred as a result of the customer manipulating the tip shape of the wire.Based upon the information provided, inspection of the returned product, and the results of our investigation; a definitive root cause for the missing j tip could not be determined.However, the damage to the outer layer of the wire is most likely attributed to the product being modified by the user.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: STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7043101
• Report Number: 1820334-2017-03907
• Device Sequence Number: 1798761
• Product Code: DQX
• UDI-Device Identifier: 00827002003620
• UDI-Public: (01)00827002003620(17)220827(10)8097895
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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
• Report Date (Section B): 02/21/2018

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: G00362
• Device Catalogue Number: TDOC-35-145-0-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1