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

Model Number	2777
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.A 185cm j tip pt guidewire was selected for use.However, it was noted that the wire was torn at its tip while coming out of the cover.No patient complications were reported.
Event or Problem Description
It was reported that tip detachment occurred.A 185cm j tip pt guidewire was selected for use.However, it was noted that the wire was torn at its tip while coming out of the cover.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: device was returned for analysis.The device has the distal tip kinked.The polymer of the tip and the guidewire coating were in good condition.The outer diameter of the distal tip, middle and proximal sections of the device 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: 8670660
• Report Number: 2134265-2019-06400
• Device Sequence Number: 381156
• Product Code: DQX
• UDI-Device Identifier: 08714729471219
• UDI-Public: 08714729471219
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 09/04/2019

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: 10/23/2020
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0022836401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1