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

Model Number	39615
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: (b)(6) 2022 was use since event date was not provided.Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that tip detachment and removal difficulties occurred.A 035/260/3mm amplatz super stiff guidewire was inserted into the target lesion.However, the guidewire broke during the procedure.The physician tried to move it but could not.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: (b)(6) 2022 was used since event date was not provided.E1 initial reporter address 1: (b)(6).Device evaluated by mfr.: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire was returned, and it was kinked at several parts of the distal end.Confirming the reported guidewire "difficult to remove".Under microscope no other damages were observed at distal tip section.The outer diameter of the distal tip, middle section, proximal section and the overall length were within specification.
Event or Problem Description
It was reported that tip detachment and removal difficulties occurred.A 035/260/3mm amplatz super stiff guidewire was inserted into the target lesion.However, the guidewire broke during the procedure.The physician tried to move it but could not.No patient complications were reported.
Additional Manufacturer Narrative
Corrected h6: evaluation conclusion code.B3 date of event: (b)(6) 2022 was use since event date was not provided.E1 initial reporter address 1: (b)(6).Device evaluated by mfr.: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire was returned, and it was kinked at several parts of the distal end, no other damages were observed.Under microscope it no damages were observed at distal tip section.The outer diameter of the distal tip, middle section, proximal section and the overall length were within specification.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that tip detachment and removal difficulties occurred.A 035/260/3mm amplatz super stiff guidewire was inserted into the target lesion.However, the guidewire broke during the procedure.The physician tried to move it but could not.No patient complications were reported.

• 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: 15258519
• Report Number: 2124215-2022-29457
• Device Sequence Number: 20501194
• Product Code: DQX
• UDI-Device Identifier: 08714729115861
• UDI-Public: 08714729115861
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2022

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: 03/29/2025
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0029135201
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 11/22/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 11/22/2022; 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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