MAUDE Adverse Event Report: COOK INCORPORATED COOK; WIRE, GUIDE, CATHETER

Model Number	G01730
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Movable core guidewire (ref number- g01730) broke while inside patient.Center portion of wire came detached from outer "sleeve" portion.Both parts were successfully removed from patient but md performing cath stated that it would have been possible for the inner core to have been left inside the patient.A staff member in the room states that she has seen this on one other occasion but it was not reported.
Event or Problem Description
Movable core guidewire (ref number- (b)(4)) broke while inside patient.Center portion of wire came detached from outer "sleeve" portion.Both parts were successfully removed from patient but md performing cath stated that it would have been possible for the inner core to have been left inside the patient.A staff member in the room states that she has seen this on one other occasion but it was not reported.

• Brand Name: COOK
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9523267
• Report Number: 9523267
• Device Sequence Number: 2313400
• Product Code: DQX
• UDI-Device Identifier: 00827002017306
• UDI-Public: (01)00827002017306(17)240925(10)9945399
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019
• Report Date (Section F): 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G01730
• Device Catalogue Number: TCMTNA-35-145-1.5
• Device Lot Number: 9945399
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 71
• Date Report Sent to FDA: 12/23/2019