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

Model Number	39575
Medical Device Problem Codes	Entrapment of Device (1212); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the guidewire became entrapped.A 035/145 amplatz super stiff guidewire was selected for use.During an exchange of of a non-bsc nephrostomy tube, the amplatz guidewire became entrapped.Upon removal of both the nephrostomy tube and amplatz, the distal end of the amplatz had unraveled.
Additional Manufacturer Narrative
E1 - initial reporter title: (b)(6).Device evaluated by mfr.: the device was returned with the distal end loaded in an unknown catheter.The returned guidewire was kinked at distal end.The coil was unraveled and stretched.Additionally, the solder ball was detached from core wire distal end.The devices were unloaded without issues.No more visual damages were found on the device.Under microscope inspection, it was possible to observe the inner corewire detached from the solder ball.Dimensional analysis was performed, and the outer diameters of the proximal, middle, and distal sections were all found to be within specification.
Event or Problem Description
It was reported that the guidewire became entrapped.A 035/145 amplatz super stiff guidewire was selected for use.During an exchange of a non-bsc nephrostomy tube, the amplatz guidewire became entrapped.Upon removal of both the nephrostomy tube and amplatz, the distal end of the amplatz had unraveled.

• 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: 13696517
• Report Number: 2134265-2022-01846
• Device Sequence Number: 20452287
• Product Code: DQX
• UDI-Device Identifier: 08714729115946
• UDI-Public: 08714729115946
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K843012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 08/02/2024
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0027770742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown