MAUDE Adverse Event Report: COOK INC COPE STAINLESS STEEL MANDRIL WIRE GUIDE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device pro code: dqx.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a patient underwent a drainage procedure.After placing a drainage tube in the patient the user noticed that the tip of the guide had detached during withdrawal.The flexible part of the guide wire remained in the cavity to drain.A section of the device did remain inside the patient's body.
Additional Manufacturer Narrative
A review of the device history record, instructions for use (ifu), manufacturing instructions, and quality control 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.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: "withdrawal or manipulation of distal spring coil portion of wire guide through needle tip may result in breakage and/or damage.Based on the information provided, no product returned and the results of our investigation, it is feasible that a section of the coil caught on the introducing needle, encountering force beyond design requirements when attempting to manipulate and/or remove the mandrill guide; however, definitive root cause could not be determined without an examination of the actual device.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: COPE STAINLESS STEEL MANDRIL WIRE GUIDE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6066177
• Report Number: 1820334-2016-01231
• Device Sequence Number: 360328
• Product Code: DQX
• UDI-Device Identifier: 00827002051775
• UDI-Public: (01)00827002051775(17)200901(10)6142306
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PMG-18-60-COPE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2016
• Supplement Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other