MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number	39615
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guide wire fracture occurred.The target lesion was located in the left superior pulmonary vein.A 6f expo guide catheter and an amplatz super stiff guidewire were selected for use.The amplatz super stiff was used for the transseptal sheath to cross the left atrium.During the procedure with the expo, the transseptal dilator was removed and the expo pigtail was advanced over the wire midway up.Once the pigtail was torqued at the tip of the wire, it was seen that the wire had sheared into two parts.One part of the wire was protruding from the sidewall of the pigtail and the other had tilt through the distal tip.The wire and the catheter were removed.The procedure was completed with another of same device.No patient complications were reported.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9825743
• Report Number: 2134265-2020-02970
• Device Sequence Number: 14220067
• Product Code: DQX
• UDI-Device Identifier: 08714729115861
• UDI-Public: 08714729115861
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K843012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

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: 12/09/2022
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0024906081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1