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

Model Number	G00763
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The tdw-25-100-5 was advanced from the radial artery during the procedure.The metallic part of the the proximal end of the wire guide separated from the deflector handle while being used and the wire guide became impossible to manipulate.Another manufacturer's wire guide was used instead without problems.No adverse effects to the patient due to this occurrence.
Additional Manufacturer Narrative
Corrected information: product code: dqx.Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used reuter tip deflecting wire guide was returned for investigation.The wire guide handle does not activate the distal end of wire guide.The proximal portion of the handle is separated from the distal portion of the handle.The connection cap was not returned.The wire is partially separated at the distal end of the handle.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 and subassembly device history records, show no nonconforming events.In addition, there were no other reported complaints for this lot number.The wire was partially separated which could be a result of excessive force.Per the ifu, "do not use excessive force when deflecting a reuter tip deflecting wire guide.Excessive use of force can result in damage to the wire guide." 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: 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: 7040983
• Report Number: 1820334-2017-03904
• Device Sequence Number: 18857345
• Product Code: DXQ
• UDI-Device Identifier: 00827002007635
• UDI-Public: (01)00827002007635(17)220703(10)7997000
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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: G00763
• Device Catalogue Number: TDW-25-100-5
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1