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

Model Number	39575
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.
Event or Problem Description
It was reported that removal difficulty occurred.An amplatz super stiff guidewire was selected for use.During removal from the patient, the guidwire felt stuck.The guidewire was removed; however it was a little bit longer and it appeared that part of the wire was laced up.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that removal difficulty occurred.An amplatz super stiff guidewire was selected for use.During removal from the patient, the guidwire felt stuck.The guidewire was removed; however it was a little bit longer and it appeared that part of the wire was laced up.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by mfr: the guidewire was returned together with its original opened pouch.The coiled wire was unraveled and stretched.The corewire was separated from the distal solder ball; it measured approximately 180 cm from the proximal end.No more visual damages were found in the device.Dimensional inspection of the overall length and outer diameter of the distal tip could not be performed due to the device condition.The dimensions for the outer diameter of the middle and proximal sections of the device were within specification.

• 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: 10009419
• Report Number: 2134265-2020-05647
• Device Sequence Number: 2897052
• Product Code: DQX
• UDI-Device Identifier: 08714729115823
• UDI-Public: 08714729115823
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K843014
• 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): 06/11/2020

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: 09/23/2022
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0024485134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1