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

Model Number	2781
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 300cm moderate support straight pt2 wire broke during dilation of a non-bsc balloon.The physician was able to get the wire out and there were no patient issues.
Event or Problem Description
It was reported that the 300cm moderate support straight pt2 wire broke during dilation of a non-bsc balloon.The physician was able to get the wire out and there were no patient issues.The device was returned and analysis was completed.Analysis of returned product revealed one kink approximately at the distal section.Also it was found the wire broken and slightly bent on its distal tip.

• 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: 7979730
• Report Number: 2134265-2018-61855
• Device Sequence Number: 11172723
• 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): 11/21/2018

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: 06/24/2020
• Device Model Number: 2781
• Device Catalogue Number: 2781
• Device Lot Number: 0022300208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1