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

Model Number	39575
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 12-jan-2022.It was reported that guidewire damage was encountered.The patient presented with may-thurner syndrome (mts).A 035/260 (bx/1) amplatz super stiff guidewire was selected for use.However, during unpacking, it was noted that the guidewire was uncoiled and was never inserted into the patient's body.The procedure was completed with another of same device.No patient complications were reported.However, returned device analysis revealed distal end detachment.
Additional Manufacturer Narrative
Device eval by mfr: unit returned with its original pouch batch 28239122, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn provided by the customer.The returned device was inspected and it had the distal tip bent and unraveled.The device was received outside the protective hoop.No more visual damages were found in the device.Detailed pictures of the tip damage were taken and it was possible to observed the coil bent and unraveled.Additionally, the solder ball was detached from core wire.

• 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: 13474848
• Report Number: 2134265-2022-00543
• Device Sequence Number: 19865736
• Product Code: DQX
• UDI-Device Identifier: 08714729295747
• UDI-Public: 08714729295747
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K843015
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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: 10/19/2024
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0028239122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: Black Or African American