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

Model Number	39575
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The coil wire of the device was unraveled.On some sections of the coil the coating was damaged (peeled).The outer diameter of the middle and proximal sections of the device are within specifications.
Event or Problem Description
Reportable based on device analysis completed on 16 jul 2019.It was reported that unraveled material was encountered.A s/s gw/035/145 (bx/1) amplatz super stiff guidewire was selected for use.However, during preparation, the wire became uncoiled.It did not enter into the patient's body.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed a coating peeling or sheared.

• 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: 8890428
• Report Number: 2134265-2019-08636
• Device Sequence Number: 2587680
• Product Code: DQX
• UDI-Device Identifier: 08714729295716
• UDI-Public: 08714729295716
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K843015
• 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): 08/13/2019

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: 03/04/2022
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0023439978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1