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 Patient Involvement (2645)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(4).
Event or Problem Description
It was reported that guidewire fracture occurred.A pt2 light support 185cm straight guidewire was selected for use.However, during unpacking, the device fractured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that guidewire fracture occurred.A pt2 light support 185cm straight guidewire was selected for use.However, during unpacking, the device fractured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
E1- initial reporter facility name: (b)(6).Device evaluated by mfr.: the unit was returned with its original pouch.There was no identify failures or evidence that could be lost due to decontamination proess, as part of overall visual revision.The guidewire does not have visual defects.Guidewire without visual defects confirmed.The outer diameter of distal, medium, and proximal sections are within specifications.

• 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: 10949313
• Report Number: 2134265-2020-16875
• Device Sequence Number: 11592525
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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: 01/19/2022
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0025069799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 60