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

Model Number	2000
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	06/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 182cm j choice guidewire was selected for use; however, upon removal from the protective case, it was noticed that the guidewire tip was damaged and broken.The procedure was completed with another of same device.No complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original box labeled batch 26480125.The unit returned has tip damaged, as part of overall visual revision.The returned guidewire had the spring tip bent/kink.The spring tip is stretched.The device was measured in three sections (distal - medium - proximal) along it in order to confirm that is within specification.
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 182cm j choice guidewire was selected for use; however, upon removal from the protective case, it was noticed that the guidewire tip was damaged and broken.The procedure was completed with another of same device.No complications were reported and the patient status was stable.

• Brand Name: CHOICE
• 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: 12233197
• Report Number: 2134265-2021-09214
• Device Sequence Number: 19753196
• Product Code: DQX
• UDI-Device Identifier: 08714729252351
• UDI-Public: 08714729252351
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2022
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: 0026480125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• 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
• Patient Age: 55 YR
• Patient Sex: Male