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

Model Number	2779
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.During unpacking of a 185cm pt guidewire, it was noted that the device was fractured.The procedure was completed with another of the same device.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that guidewire fracture occurred.During unpacking of a 185cm pt guidewire, it was noted that the device was fractured.The procedure was completed with another of the same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire does not have visual defects.The surface of the device was carefully inspected and no abnormalities were observed, there were no fractures or breakage of the device.The device was measured in three sections (distal - medium - proximal) that is within specification.

• 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: 11386261
• Report Number: 2134265-2021-02338
• Device Sequence Number: 17005211
• Product Code: DQX
• UDI-Device Identifier: 08714729471103
• UDI-Public: 08714729471103
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: 03/11/2022
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0025343970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 66