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

Model Number	2560
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coating peeled requiring intervention.The 40% stenosed target lesion was located in the slightly tortuous left popliteal artery/tibia peroneal trunk artery.A 300cm ptgraphix guidewire was advance to cross the lesion.However, during the procedure, the hydrophilic coating came off inside the patient.The fragment was not able to be retrieved, and angioplasty was performed to push the hydrophilic coating out of the way.The device fragment was left inside the patient's body, and the procedure was completed using an alternate device.No patient harm was reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of choice ptgraphix intermediate300cmj5pk guidewire.A visual and microscopic examination revealed coating of the distal tip was missing.Distal section was observed bent.Dimensional analysis of the guidewire was measured, and it was found that the length was not accordance to the drawing.Because the total length of the guidewire was of 298 cm and per drawing it should be 300 cm.Based on the evidence, the as reported code of "hydrophilic guidewire fracture" can be confirmed.
Event or Problem Description
It was reported that the coating peeled requiring intervention.The 40% stenosed target lesion was located in the slightly tortuous left popliteal artery/tibia peroneal trunk artery.A 300cm ptgraphix guidewire was advance to cross the lesion.However, during the procedure, the hydrophilic coating came off inside the patient.The fragment was not able to be retrieved, and angioplasty was performed to push the hydrophilic coating out of the way.The device fragment was left inside the patient's body, and the procedure was completed using an alternate device.No patient harm was reported.

• Brand Name: PT GRAPHIX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18725070
• Report Number: 2124215-2024-07354
• Device Sequence Number: 20319263
• Product Code: DQX
• UDI-Device Identifier: 08714729141976
• UDI-Public: 08714729141976
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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: 11/02/2025
• Device Model Number: 2560
• Device Catalogue Number: 2560
• Device Lot Number: 0032778412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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: Other; Required Intervention
• Patient Sex: Unknown