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

Model Number	2480
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire tip detached.A pt graphix guidewire was selected for use in a percutaneous coronary intervention.During the procedure, the radiopaque tip detached inside the patient.The tip could not be removed from the patient.The tip was moved to a location which would not be a detriment to the patient.No further patient complications were reported and the patient was well post-procedure.
Additional Manufacturer Narrative
Device analysis by mfr: the returned guidewire had the distal tip bent and a section of the polymer tip was detached.The detached section was not returned.The damaged section was located approximately at 181.8 cm from the proximal end.No more damages were found in the device.The overall length of the guidewire could not be measured to the detached tip.The outer diameter of the distal tip could not measured due to the detached tip.The outer diameter of the middle and proximal sections of the guidewire were within specification.
Event or Problem Description
It was reported that the guidewire tip detached.A pt graphix guidewire was selected for use in a percutaneous coronary intervention.During the procedure, the radiopaque tip detached inside the patient.The tip could not be removed from the patient.The tip was moved to a location which would not be a detriment to the patient.No further patient complications were reported and the patient was well post-procedure.

• Brand Name: PT GRAPHIX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9490090
• Report Number: 2134265-2019-15927
• Device Sequence Number: 16201811
• Product Code: DQX
• UDI-Device Identifier: 08714729141730
• UDI-Public: 08714729141730
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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: 08/25/2021
• Device Model Number: 2480
• Device Catalogue Number: 2480
• Device Lot Number: 0024331584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/14/2020
• 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: Required Intervention