MAUDE Adverse Event Report: COOK INC REUTER TIP DEFLECTING WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G00374
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This mdr is being filed after the associated complaint was reviewed under remediation protocol cap (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The complainant reported that the tip of the reuter tip deflecting wire guide could not be deflected for the cardiac catherization of a pediatric patient.The side arm adaptor was not used for the procedure.It was further noted that both solder connections located at the distal end were broken.The product problem did not result in any reported serious injuries to the patient.

• Brand Name: REUTER TIP DEFLECTING WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7906842
• Report Number: 1820334-2018-02911
• Device Sequence Number: 1665250
• Product Code: DQX
• UDI-Device Identifier: 00827002003743
• UDI-Public: (01)00827002003743(17)200831(10)6114359
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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 Expiration Date: 08/31/2020
• Device Model Number: G00374
• Device Catalogue Number: TDW-25-80-5
• Device Lot Number: 6114359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1