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	Foreign Body In Patient (2687)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the guidewire detached and remained inside the patient.A pt graphix guidewire was selected for use in a percutaneous coronary intervention (pci) to treat coronary heart disease.During the procedure, the radiopaque tip broke off.The device fragment could not be retrieved and was left inside the patient.The pci was successfully completed with another of the same device.The patient was expected to fully recover.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned guidewire was not complete, only a section of approximately 70.7 inches was returned.The remaining 1.3 inch portion of the polymer jacket was detached and not returned.The distal, medium and proximal sections of the device were measured and were found to be within specification.The distal outer diameter measurement could not be performed due to device condition.
Event or Problem Description
It was reported that the tip of the guidewire detached and remained inside the patient.A pt graphix guidewire was selected for use in a percutaneous coronary intervention (pci) to treat coronary heart disease.During the procedure, the radiopaque tip broke off.The device fragment could not be retrieved and was left inside the patient.The pci was successfully completed with another of the same device.The patient was expected to fully recover.

• 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: 11654207
• Report Number: 2134265-2021-04062
• Device Sequence Number: 11665162
• Product Code: DQX
• UDI-Device Identifier: 08714729141723
• UDI-Public: 08714729141723
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/02/2021

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: 01/15/2023
• Device Model Number: 2480
• Device Catalogue Number: 2480
• Device Lot Number: 0026643213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 06/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other