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

Model Number	2000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.A 182cm choice guidewire was selected for use.However, it was found that the device was fractured when removing it from its packaging.The procedure was completed.
Additional Manufacturer Narrative
D4: lot number updated.
Event or Problem Description
It was reported that guidewire fracture occurred.A 182cm choice guidewire was selected for use.However, it was found that the device was fractured when removing it from its packaging.The procedure was completed.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual & microscope inspection revealed a kink at the end of the spring tip.The dimensional inspection confirmed that the total length of the guidewire is within the nominal limits.The guidewire received for analysis revealed no sign of fractures.Inspection of the media received does not show any evidence of the reported issue.Based on the evidence, the as reported code of "guidewire fracture" cannot be confirmed.
Event or Problem Description
It was reported that guidewire fracture occurred.A 182cm choice guidewire was selected for use.However, it was found that the device was fractured when removing it from its packaging.The procedure was completed.

• Brand Name: CHOICE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia MN ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18887818
• Report Number: 2124215-2024-11093
• Device Sequence Number: 16903581
• Product Code: DQX
• UDI-Device Identifier: 08714729252375
• UDI-Public: 08714729252375
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2024

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: 09/21/2024
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: 0030202582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 06/05/2024; 07/31/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 06/27/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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 Sex: Unknown