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

Model Number	1920
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	07/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: (b)(6).
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the left circumflex coronary artery.A 300cm j choice extra support guidewire was advanced to cross the lesion.However, it was noted that balloon could not pass across that wire.Physician wanted to use a different wire and pulled the wire out.When device was removed, it was noted that the wire caught in the vessel and the tip portion was fractured and broke off inside the patient.The physician pulled the rest of the remaining of the wire out, but part of the wire still stayed inside the patient.An attempt to snare the detached part of the tip was done, but it was unsuccessful.The detached part of the tip was left inside the patient's body.No further patient complications were reported and the patient's status was fine.

• Brand Name: CHOICE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8831502
• Report Number: 2134265-2019-08752
• Device Sequence Number: 13983083
• Product Code: DQX
• UDI-Device Identifier: 08714729193685
• UDI-Public: 08714729193685
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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: 09/27/2020
• Device Model Number: 1920
• Device Catalogue Number: 1920
• Device Lot Number: 0022721978
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/26/2019
• 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: Other
• Patient Age: 78 YR