MAUDE Adverse Event Report: COOK INC STRAIGHT FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that during an unspecified procedure, using a straight fixed core wire guide, the guide wire tore apart.Additionally, it was reported that there was no clinical significance/no known injury or impact on the patient due to this occurrence.
Additional Manufacturer Narrative
Corrected information: product code dqx.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used straight fixed wire guide was returned for investigation.Distal weld is not connected to the core wire.The surface coils were free of damage.A document-based investigation was performed.There is no evidence to suggest the product was not manufactured to current specifications.There is no evidence to suggest all items in the lot or similar devices in the field are nonconforming or defective.There is no evidence the product was damaged upon opening.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.Each device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.A complaint history search revealed this complaint to be the only reported complaint associated to the complaint lot number.There is no information regarding the procedure and any difficulties that may have contributed to the device failure.There is no information regarding if the device was removed through a needle.There is no information regarding the patient's anatomy that may have contributed to the device failure.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: STRAIGHT 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: 6665552
• Report Number: 1820334-2017-01421
• Device Sequence Number: 16637010
• Product Code: DXQ
• UDI-Device Identifier: 00827002006508
• UDI-Public: (01)00827002006508(17)211214(10)7470675
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/12/2017

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: TSF-35-145
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1