MAUDE Adverse Event Report: COOK, INC. COOK MOTION HYBRID WIRE GUIDE; WIRE, GUIDE, CATHETER

Model Number	MHW-035150
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During a cystoscopy, a cook motion hybrid wire guide (mhw-035150; g44846), lot number: 9006229355 was placed in the left ureter in preparation for a stent placement.It was noted the blue wire coating (nitinol with hydrophilic tip) came off wire and was in the bladder.You can see on the picture, the end of the wire is missing the blue coating.Fda safety report id# (b)(4).

• Brand Name: COOK MOTION HYBRID WIRE GUIDE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 10991575
• Report Number: MW5098311
• Device Sequence Number: 19027017
• Product Code: DQX
• UDI-Device Identifier: 00827002448469
• UDI-Public: (01)00827002448469(17)230707(10)
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 07/07/2023
• Device Model Number: MHW-035150
• Device Catalogue Number: G44846
• Device Lot Number: 9006229355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2020
• 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
• Patient Age: 67 YR
• Patient Weight: 100