MAUDE Adverse Event Report: COOK INC COPE NITINOL MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: dqx.Occupation: operations supervisor.Pma/510(k) #: preamendment.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 a cope nitinol mandril wire guide was used in an unknown patient for an unknown procedure.As reported, the device "broke while inside patient's vessel." it is unknown if the procedure was completed.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
Additional information: b5- additional information was provided on 28jun2019 and 11jul2019.The information states that the patient was a three year old, white, female weighing 5 kg.With tetralogy of fallot status post repair.It was reported that there were no concerns about variant anatomy.The device was being used for placement of a right femoral venous central line.During placement, the needle position was confirmed in the vessel, but "the wire did not pass on the first attempt." resistance was felt when the wire was pulled back.The operator reported "with slightly increased force, the wire 'gave way,' and was noted to be coming apart." the needle was then removed from the patient and the tip was noted to be intact.A new central kit was obtained and completed on the opposite side femoral vein.No adverse effects on the patient were reported.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.
Additional Manufacturer Narrative
Product received on: (b)(6) 2019.A review of the complaint history, device history record, drawing, manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.One used wire guide and needle and 19 unused devices within the original packaging were returned for investigation.The used wire guide was returned in a damaged, elongated, and unraveled condition and remained inserted through the needle.The distal end of the wire guide was sticking out of the end of the needle.The unraveling of the coil begins around the location of the proximal weld and extends through the needle.The most distal end of the wire remains attached to the unraveled coiling.Dimensional analysis of the coil confirmed that the device was within the correct specifications and tolerances.No damage was noted on any of the unused, returned devices.There was no evidence to suggest the devices were not manufactured within the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.All tested devices met the acceptance criterion for resistance to damage during flex testing.The device history record for the complaint lot revealed one nonconformance for offset coil and two devices were identified and scrapped out.This issue is inspected 100% prior to lot release.The coil subassembly lot revealed no reported nonconformances.A database search revealed no other complaints have been reported from the lot.As proper inspection activities are in place, all related nonconformances were identified and scrapped out prior to release, and no other complaints have been reported for the potential lots, there is no evidence to suggest there is any nonconforming product in house or out in the field.Product labeling was also reviewed as a part of the investigation.A label is attached to the wire guide holder and illustrates that withdrawal and/or manipulation of the distal spring coil portion of the wire guide through the needle tip may result in breakage.Based on the information provided, the examination of returned product and the results of the investigation, it was determined that unintended use error caused or contributed to the event.Withdrawing the wire guide through a needle can cause damage to the wire guide due to the sharp bevel tip of the needle, typically leading to unraveling of the wire.The labeling attached with the device warns against manipulating the wire through the needle.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COPE NITINOL MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8728638
• Report Number: 1820334-2019-01513
• Device Sequence Number: 11227660
• Product Code: DXQ
• UDI-Device Identifier: 00827002084278
• UDI-Public: (01)00827002084278(17)231113(10)9279528
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2019

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: 11/13/2023
• Device Model Number: N/A
• Device Catalogue Number: PMG-18SP-60-COPE-NT
• Device Lot Number: 9279528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 06/28/2019; 08/28/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/16/2019; 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 5