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

Model Number	39575
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned in a generic plastic bag.Unit returned with a stent stuck in it.Media inspection showed costumer attached a picture of the device, and it is possible to observe that the guidewire was inside a stent, nevertheless no possible damages were observed to the guidewire.Visual and microscope inspection showed guidewire was returned stuck inside a stent.It was observed that the coil wire was unraveled, and the core wire at distal section and under microscope it was observed that the coil wire was unraveled, and the core wire was detached at transition section of the distal part.Outer diameter of distal tip, middle of the device, and proximal section are within specification.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
Reportable based on device analysis completed on 23-nov-2022.It was reported that difficulty tracking over wire was encountered.The patient presented with kidney stone.The stenosed target lesion was located in the non-calcified and non-tortuous kidney.A 035/145 amplatz super stiff guidewire was advanced for use.However, during the procedure, it did not allow the stent to pass over the wire.The device was removed and the procedure was completed with a non-bsc guidewire.No patient complications were reported.However, returned device analysis revealed that the core wire was detached.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15960677
• Report Number: 2124215-2022-49898
• Device Sequence Number: 12038958
• Product Code: DQX
• UDI-Device Identifier: 08714729115946
• UDI-Public: 08714729295723
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K843017
• 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): 12/12/2022

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: 04/20/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0029264904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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