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

Model Number	2480
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that difficulty removing a guidewire and guidewire detachment occurred.The 80% stenosed target lesion was located in the highly calcified circumflex (cx) and left anterior descending artery (lad).Due to the bifurcation treatment (cx to lad), a 2.5 x 20mm promus select stent was implanted in the lad.For a kissing balloon treatment, a 182cm pt graphix guidewire was inserted into the lad and the wire was placed undetected under a stent strut.After the kissing balloon treatment, the pt graphix wire was removed, but resistance was felt.During removal, 3mm of the pt graphix wire tip was torn off and fixed under the stent strut.No intervention was performed to remove the tip from the patient as it was not possible to cross the stenosis and so it was not possible to remove the tip from the patient.It was noted that the reason for the tip detachment was due to the bifurcation stenosis.The procedure was completed.No patient complications resulted from this event and the patient was reported to be stable following the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Visual inspection was performed.The device has 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 cm from the proximal end.The body was kinked approximately at 0.8 cm from the proximal end.No more damages were found in the device.The outer diameter of the middle and proximal section of the device were within specification.
Event or Problem Description
It was reported that difficulty removing a guidewire and guidewire detachment occurred.The 80% stenosed target lesion was located in the highly calcified circumflex (cx) and left anterior descending artery (lad).Due to the bifurcation treatment (cx to lad), a 2.5 x 20mm promus select stent was implanted in the lad.For a kissing balloon treatment, a 182cm pt graphix guidewire was inserted into the lad and the wire was placed undetected under a stent strut.After the kissing balloon treatment, the pt graphix wire was removed, but resistance was felt.During removal, 3mm of the pt graphix wire tip was torn off and fixed under the stent strut.No intervention was performed to remove the tip from the patient as it was not possible to cross the stenosis and so it was not possible to remove the tip from the patient.It was noted that the reason for the tip detachment was due to the bifurcation stenosis.The procedure was completed.No patient complications resulted from this event and the patient was reported to be stable following the 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: 9410528
• Report Number: 2134265-2019-14829
• Device Sequence Number: 4202740
• Product Code: DQX
• UDI-Device Identifier: 08714729188469
• UDI-Public: 08714729188469
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/31/2020

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 Model Number: 2480
• Device Catalogue Number: 2480
• Device Lot Number: 0022981924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/31/2020
• 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
• Patient Age: 82 YR