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

Model Number	39575
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire distal tip detached.A.035 x 260 cm amplatz guidewire was selected for use in a filter retrieval.During preparation, while the device was external to the patient, the distal tip was observed to be detached.
Event or Problem Description
It was reported that the guidewire distal tip detached.A.035 x 260 cm amplatz guidewire was selected for use in a filter retrieval.During preparation, while the device was external to the patient, the distal tip was observed to be detached.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device was inspected and it had the distal tip kinked.It's important to mention that the device was received outside the original pouch and 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 distal tip kinked.The outer diameter of the distal tip, middle section and proximal section were within specification.

• 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: 13155271
• Report Number: 2134265-2021-16285
• Device Sequence Number: 14489856
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• 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: 10/07/2024
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0028169759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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: 62 YR
• Patient Sex: Male