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

Model Number	39695
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire coating detached, and the guidewire was difficult to remove.A 0.038in x 75cm amplatz super stiff guidewire was selected for use in a bilateral nephrostomy procedure on a high dependency unit (hdu) patient to drain the kidneys.During the procedure, the coating became detached at the distal segment, which left the wire edgy and difficult to use.The bare wire was not smooth and without the coating, it was difficult to retract.No device fragments were left inside the patient.The procedure was completed with another of the 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14400446
• Report Number: 2134265-2022-05511
• Device Sequence Number: 20206134
• Product Code: DQX
• UDI-Device Identifier: 08714729295761
• UDI-Public: 08714729295761
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K843019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2022

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: 07/05/2024
• Device Model Number: 39695
• Device Catalogue Number: 39695
• Device Lot Number: 0027617674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown