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

Model Number	39695
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: event date was not reported and was approximated to (b)(6) 2021.Device eval by manufacturer: the guidewire was returned with a portion of the wire stuck inside a non-boston scientific catheter.Visual and microscopic inspection revealed that the guidewire was unraveled, the coiled wire was stretched along the distal end, and the core wire was broken.An unknown non-boston scientific catheter device was returned with the coil distal tip trapped inside.The guidewire was unloaded without issues.No other visual damages were observed.Dimensional inspection was performed, and the outer diameters of the proximal, middle, and distal sections of the guidewire were found to be within specifications.
Event or Problem Description
Reportable based on device analysis completed on 15feb2021.It was reported that a 0.035in x 75cm amplatz super stiff guidewire became stuck inside a non-boston scientific sheath.While attempting to remove the wire, it became stretched.However, device analysis revealed that the wire was fractured.

• 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: 11395220
• Report Number: 2134265-2021-02551
• Device Sequence Number: 3302499
• Product Code: DQX
• UDI-Device Identifier: 08714729295754
• UDI-Public: 08714729295754
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K843017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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: 09/16/2023
• Device Model Number: 39695
• Device Catalogue Number: 39695
• Device Lot Number: 0026027214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1