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

Model Number	2779
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire tip fracture occured.A 185cm str, pt guide wire was advanced to cross the lesion.However, the physician found that the tip of the guide wire was fractured.The device was removed with a snare and no debris was left inside the patient.No patient complications were reported.
Event or Problem Description
It was reported that guide wire tip fracture occurred.A 185cm str, pt guide wire was advanced to cross the lesion.However, the physician found that the tip of the guide wire was fractured.The device was removed with a snare and no debris was left inside the patient.No patient complications were reported.It was further reported that the target lesion was located in the moderately tortuous proximal left anterior descending artery with 70% stenosis.

• Brand Name: PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12417222
• Report Number: 2134265-2021-10763
• Device Sequence Number: 4724272
• Product Code: DQX
• UDI-Device Identifier: 08714729471189
• UDI-Public: 08714729471189
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 01/15/2022
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0025057077
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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: 78 YR