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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: dqx.Occupation: unknown.Pma/510(k) #: 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 a cope nitinol mandril wire guide was used during an insertion of a picc line.As reported, the user experienced resistance when attempting to remove the guide wire.Upon inspection the wire was ¿frayed¿ in the middle.The user was able to remove the device successfully from the vein of the patient.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
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional information: 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.
Event or Problem Description
Additional information was provided on 25feb2019.It was reported an attempt was made to place the peripherally inserted central catheter (picc) in the three veins in the left arm.The veins were reportedly too "small." when the guide was placed in the humeral vein of the right arm, it took 15 minutes to remove it.The procedure was completed by placing a picc line higher on the right arm.
Additional Manufacturer Narrative
Investigation, evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of the investigation, a definitive root cause could not be determined.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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: 8320101
• Report Number: 1820334-2019-00178
• Device Sequence Number: 19276190
• Product Code: DQX
• UDI-Device Identifier: 00827002084278
• UDI-Public: (01)00827002084278(17)230215(10)8547719
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 03/05/2019

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: 02/15/2023
• Device Model Number: N/A
• Device Catalogue Number: PMG-18SP-60-COPE-NT
• Device Lot Number: 8547719
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 02/25/2019; 03/19/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 03/05/2019; 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR