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

Model Number	N/A
Medical Device Problem Codes	Unraveled Material (1664); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: technician.Pma/510(k) #: pre-amendment.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported an unknown patient required placement of a cope mandril wire guide for an unknown procedure.The operator noticed the "wire tip began to unravel while in the patient" and elongated.The procedure was completed with another device however the identity of that device was not confirmed.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: a2, a3, a4, b5, h6.A4 - weight: 72.4 kg.B5 - event description: additional information was provided on 09oct2019.As reported, "there was kinking of wire when dr.Tried to advance under fluoro." the wire was inserted into the patient "2 or 3 times before it unraveled and almost got stuck." the wire was removed through the 5f dilating sheath.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
See h10.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation - evaluation: a review of documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications, as well as a visual inspection, dimensional verification, and a functional test of the returned device was conducted during the investigation.One used cope wire was returned for evaluation.A physical examination showed that the wire was unraveled but not separated.The weld ball was intact.An attempt was made to remove the wire from the catheter, however the wire was stuck inside the catheter.The mandril wire was visible.The distal portion of the wire was not unraveled.The undamaged portion of the wire was re-advanced through the dilator, but the failure mode could not be recreated.Dimensions deemed relevant to the failure mode were analyzed and it was found that the device was manufactured within specification.Additionally, a document-based investigation evaluation was conducted.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to release.Risk analysis indicates that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record for lot 9855913 found no nonconformances that could have contributed to the failure mode.It should be noted that there were no other complaints reported for this lot number.There is no evidence to suggest that nonconforming product exists in house or in the field.Product labeling was also reviewed.The label attached to the wire guide holder 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, examination of the returned product and the results of our investigation, it was concluded that a component failure without a manufacturing or design issue contributed to the failure mode.It is possible that removing or manipulating the wire within the dilating sheath could have caused the unraveling, but this cannot be confirmed.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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 new event description information to report at this time.
Additional Manufacturer Narrative
B5 - the procedure was completed by opening a competitor's wire and deciding to do a central line rather than a picc line.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.

• Brand Name: COPE MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9146943
• Report Number: 1820334-2019-02520
• Device Sequence Number: 19541003
• Product Code: DXQ
• UDI-Device Identifier: 00827002051836
• UDI-Public: (01)00827002051836(17)240729(10)9855913
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 12/16/2019

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: 07/29/2024
• Device Model Number: N/A
• Device Catalogue Number: PMG-18SP-60-COPE
• Device Lot Number: 9855913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 10/09/2019; 10/11/2019; 12/04/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/10/2019; 10/16/2019; 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 72