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

Model Number	G00763
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: dqx.Pma/510(k) number: pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, prior to patient contact, a physician found the reuter tip deflecting wire guide had separated 5cm from the hub.The separation was noted after anchoring the side-arm fitting to the handle, prior to any patient contact.The device was not used.Another manufacturer's device was used to successfully complete the procedure.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, manufacturer¿s instructions, quality control, specifications, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one prior to use reuter tip deflecting wire guide was returned for investigation.The inserter cannula was separated from the handle near the proximal mandril.During the functional test, no damage to the tip of the device was noted and when tested, the device successfully deflected without issue using the remaining portion of the mandril still attached.Additionally, a bend was located 8.3cm from the proximal end of the handle cannula.A document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states the following warnings/instructions: 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.Do not attempt deflection of wire guide until it is inserted into a catheter.Such deflection may result in damage to tip of wire.Table-top test the handle, wire guide and catheter assembly prior to use.Confirm that the wire guide does not protrude through or obstruct the catheter endhole.Ensure that the wire guide, when deflected, cannot exit through a catheter sideport.Based on the information provided and the examination of the returned product, investigation has concluded that the cause of this event can be traced to random component failure without design or manufacturing issue.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 8332437
• Report Number: 1820334-2019-00409
• Device Sequence Number: 19404401
• Product Code: DQX
• UDI-Device Identifier: 00827002007635
• UDI-Public: (01)00827002007635(17)230716(10)8984290
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: 07/16/2023
• Device Model Number: G00763
• Device Catalogue Number: TDW-25-100-5
• Device Lot Number: 8984290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1