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 Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that wire fracture occurred.The target lesion was located in a vessel in the lower limb.A 185cm pt2 guidewire was used, however; the wire fractured while inside the catheter.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The guidewire returned inside of a protective hoop.The guidewire was easily removed from the protective hoop.The guidewire was kinked approximately at 146 cm from the proximal end.No more visible damages were found in the device.Outer diameter of the distal tip, middle of the device and proximal section are within specification.
Event or Problem Description
It was reported that wire fracture occurred.The target lesion was located in a vessel in the lower limb.A 185cm pt2 guidewire was used, however; the wire fractured while inside the catheter.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.

• 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: 9986027
• Report Number: 2134265-2020-05400
• Device Sequence Number: 3896338
• 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): 06/01/2020

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: 09/11/2021
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0024424218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 66