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

Model Number	39615
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the coating peeled.An 035/260/3mm amplatz ss jtip guidewire was used during a atherectomy procedure.The amplatz wire was used to reach a specific point in the patient and then removed.The device was kept in a tray with saline.After some time, the physician tried to reintroduce the amplatz wire and the device could not go further into the 7f introducer.A section of its length was "peeled" (the blue coat of the amplatz was missing).The physician did an image but he could not notice anything in the patient.The procedure was completed with a pta coyote balloon with no patient complications.
Additional Manufacturer Narrative
Device technical analysis: the returned device was inspected and revealed the distal section was kinked.The device was received outside the original pouch and protective hoop and no detachment sections or fractures were identified.No additional visual damage was found.
Event or Problem Description
It was reported the coating peeled.An 035/260/3mm amplatz ss jtip guidewire was used during a atherectomy procedure.The amplatz wire was used to reach a specific point in the patient and then removed.The device was kept in a tray with saline.After some time, the physician tried to reintroduce the amplatz wire and the device couldn't go further into the 7f introducer.A section of its length was "peeled" (the blue coat of the amplatz was missing).The physician did an image but he couldn't notice anything in the patient.The procedure was completed with a pta coyote balloon with no patient complications.

• 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: 12590933
• Report Number: 2134265-2021-12403
• Device Sequence Number: 11857202
• Product Code: DQX
• UDI-Device Identifier: 08714729115861
• UDI-Public: 08714729115861
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 08/12/2023
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0025850222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2020
• 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: Male