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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a patient underwent a percutaneous nephrectomy procedure.During the procedure it was noticed that the tip end of the cutting wire had broken.The product was discarded.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.D.2) dqx wire, guide, catheter.Investigation - evaluation: the customer reported, "breakage of the tip end of the cutting wire during a percutaneous nephrectomy g, used with a drainage percutaneous huisman's probe - j 7.5f (merit).Product discarded." a review of the complaint history, device history record, drawings, documentation, manufacturing instructions, specifications 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.A review of device history record was conducted; the lot met all finished goods release criteria.It should be noted there were no other reported complaints for this lot number.No product was returned to aid in the investigation.A definitive root cause for failure could not be determined.We will continue to monitor for similar complaints, and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no additional mitigation activity is required at this time.H3 other text : blank fields on this form indicate the information is unknown, unavailable or unchanged.D.2) dqx wire, guide, catheter.Investigation - evaluation: the customer reported, "breakage of the tip end of the cutting wire during a percutaneous nephrectomy g, used with a drainage percutaneous huisman's probe - j 7.5f (merit).Product discarded." a review of the complaint history, device history record, drawings, documentation, manufacturing instructions, specifications 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.A review of device history record was conducted; the lot met all finished goods release criteria.It should be noted there were no other reported complaints for this lot number.No product was returned to aid in the investigation.A definitive root cause for failure could not be determined.We will continue to monitor for similar complaints, and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no additional mitigation activity is required at this time.
Additional Manufacturer Narrative
This report is being submitted retrospectively per fda request.All information for this event was previously submitted from 25oct2016-03feb2017.

• Brand Name: COPE STAINLESS STEEL MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6055273
• Report Number: 1820334-2016-01213
• Device Sequence Number: 18845751
• Product Code: DXQ
• UDI-Device Identifier: 00827002051775
• UDI-Public: (01)00827002051775(17)210422(10)6867140
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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 Model Number: N/A
• Device Catalogue Number: PMG-18-60-COPE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 03/03/2025
• Date Device Manufactured: 04/22/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown