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

Model Number	2781
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the tip of the wire detached.A 300cm pt guidewire was selected for use.During unpacking, the tip detached when it was removed from the packaging coil.The device was not used in the patient.The procedure was completed with another pt device and there were no patient complications.
Event or Problem Description
It was reported that the tip of the wire detached.A 300cm pt guidewire was selected for use.During unpacking, the tip detached when it was removed from the packaging coil.The device was not used in the patient.The procedure was completed with another pt device and there were no patient complications.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the guidewire returned inside of its protective hoop and packaging pouch.Visual inspection revealed the guidewire detached into two sections.The proximal section measured approximately 103.1 inches from the proximal end.The distal section measured approximately 14.7 inches from the distal tip.The proximal section showed different kinks located approximately at 34 inches, 42 inches and 43.5 inches from the proximal end.The distal section was kinked approximately at 10.5 inches from the distal end.The ends of the separated sections were microscopically inspected and it seemed that the separation was induced by an external factor consistent with a sharp tool.Dimensional inspection found the distal tip, middle section, and proximal section outer diameters within specification.Inspection of the remainder of the device revealed no other damage or irregularities.E1: initial reporter phone: (b)(6).

• 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: 10518218
• Report Number: 2134265-2020-12571
• Device Sequence Number: 19420667
• Product Code: DQX
• UDI-Device Identifier: 08714729471233
• UDI-Public: 08714729471233
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: 01/31/2022
• Device Model Number: 2781
• Device Catalogue Number: 2781
• Device Lot Number: 0025142020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1