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

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

The 510k status: preamendment this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The customer reported per voluntary report mw5074521, during the placement of a nephrostomy tube, the tip of the 0.018" size cope mandril wire guide broke off outside of the 21 gauge introducer needle.The break occurred at some point during the retraction of the wire, at point where the soft portion of the wire and the tip of the needle met.The wire tip became lodged in the tissue of the patient's kidney, and could not be retrieved safely.Additional information was requested from the customer, but the customer indicated that no further information would be made available.The complaint product is reportedly unavailable for return and evaluation.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, instructions for use (ifu) manufacturing instructions, quality control data, and specification of the device was conducted during the investigation.Clinical assessment: a review of the pmg-18sp-60-cope bom shows the device is packaged with caution label(s) which depict a warning to not pull the distal spring coil portion of the wire guide through the needle tip.Possible effect that can occur with wire guide separation could result in the separated portion of the wire guide remaining in the patient causing serious health complications such as perforation of vessel, thrombus and emboli resulting in serious harm (harm resulting in permanent impairment of body structure/function).At this time, the most probable cause of this event is user technique related.However, device failure related factors cannot be ruled out.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.A review of manufacturing documentation was performed and determined that steps are in place to inspect the device for dimensional and functional criteria.The device history record and search for same lot complaints could not be performed due to the lot number not being provided.There is no evidence to suggest that nonconformances exist in house or in the field.The label cautions that withdrawal of the wire through the needle may result in this reported failure.The root cause is likely to be user related.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: COPE MANDRIL WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7310011
• MDR Text Key: 101404080
• Report Number: 1820334-2018-00434
• Device Sequence Number: 1
• Product Code: DXQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PMG-18SP-60-COPE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention