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

Model Number	2777
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via user medwatch (b)(4) that tip detachment occurred.The 99% stenosed target lesion was located in the mid left anterior descending (lad) artery.A 185cm pt guidewire was advanced into the lesion.However, during the procedure, the wire tip broke off at a distal side branch of the artery.The tip did not cause chest pain and the patient remained hemodynamically stable.No evidence of perforation of the distal vessel was noted.The tip was left in place as the clinician felt that the risk to retrieve the object outweighed the risk of leaving it in.A 3.0 x 22mm drug-eluting stent was successfully placed with a reduction of stenosis in the artery to 0% and return of blood flow.No further complications were reported.
Additional Manufacturer Narrative
B5.Describe event or problem- updated.(e1) initial reporter title: updated from ms.To dr.(e1) initial reporter first name: updated from (b)(6).(e1) initial reporter last name: updated from (b)(6).(e1) initial reporter phone: updated from (b)(6).(e3) occupation: updated from nurse to physician.
Event or Problem Description
It was reported via user medwatch (b)(4) that tip detachment occurred.The 99% stenosed target lesion was located in the mid left anterior descending (lad) artery.A 185cm pt guidewire was advanced into the lesion.However, during the procedure, the wire tip broke off at a distal side branch of the artery.The tip did not cause chest pain and the patient remained hemodynamically stable.No evidence of perforation of the distal vessel was noted.The tip was left in place as the clinician felt that the risk to retrieve the object outweighed the risk of leaving it in.A 3.0 x 22mm drug-eluting stent was successfully placed with a reduction of stenosis in the artery to 0% and return of blood flow.No further complications were reported.It was further reported that the patient was stable post procedure and stayed overnight per post stent protocol.The patient was then discharged the next day.

• Brand Name: PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13343862
• Report Number: 2134265-2022-00614
• Device Sequence Number: 14442525
• Product Code: DQX
• UDI-Device Identifier: 08714729471196
• UDI-Public: 08714729471196
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: 02/10/2023
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0026790457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• 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: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Race: White