MAUDE Adverse Event Report: PT GRAPHIX; WIRE, GUIDE, CATHETER

Model Number	2520
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The 65% stenosed target lesion was located in the mildly tortuous and mildly calcified anterior descending artery.A 182cm graphix guidewire was advanced to cross the lesion.However, while manipulating the guidewire inside the vessel, resistance was encountered and approximately 3cm of the guidewire tip was left inside the artery.The physician attempted to remove the dislodged guidewire tip but it was not possible to withdraw.The procedure was completed successfully with a non-boston scientific guidewire.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that tip detachment occurred.The 65% stenosed target lesion was located in the mildly tortuous and mildly calcified anterior descending artery.A 182cm graphix guidewire was advanced to cross the lesion.However, while manipulating the guidewire inside the vessel, resistance was encountered and approximately 3cm of the guidewire tip was left inside the artery.The physician attempted to remove the dislodged guidewire tip but it was not possible to withdraw.The procedure was completed successfully with a non-boston scientific guidewire.No patient complications were reported and the patient status was stable.It was further reported that detached tip removal using a snare was attempted without success.

• Brand Name: PT GRAPHIX
• Common Device Name: WIRE, GUIDE, CATHETER
• MDR Report Key: 12620143
• Report Number: 2134265-2021-12559
• Device Sequence Number: 16445429
• Product Code: DQX
• UDI-Device Identifier: 08714729254935
• UDI-Public: 08714729254935
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2023
• Device Model Number: 2520
• Device Catalogue Number: 2520
• Device Lot Number: 0026775574
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention