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

Model Number	2779
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified right coronary artery.A 185cm j-tip pt guidewire was advanced to cross the lesion.However, while manipulating the guide wire inside the vessel, resistance was encountered and 3cm of the guide wire tip detached.The physician attempted to remove the device fragment but it was not possible to withdraw and was left inside the artery.Flow of the vessel was not compromised and vessel damage was not noticed.The procedure was completed with another of the same device.The patient was transferred to the coronary care unit to monitor possible complications of bleeding from the right groin.There were no further complications reported and the patient was stable.

• 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: 12664497
• Report Number: 2134265-2021-13153
• Device Sequence Number: 14506178
• Product Code: DQX
• UDI-Device Identifier: 08714729471127
• UDI-Public: 08714729471127
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 10/20/2021

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: 01/21/2023
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0026671602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/20/2021
• 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