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

Model Number	39575
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Initial reporter city: (b)(6).
Event or Problem Description
It was reported that coating issue occurred.The 99% stenosed target lesion was located in the mildly tortuous bile duct.A 035/145 (bx/5) amplatz super stiff guidewire was advanced for treatment.However, during the procedure, the coating was bulging or expanding slightly before the tip of the wire.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).Device eval by manufacturer: this device was returned with its original pouch from batch 28911166.Visual inspection observed that the distal end was kinked.Further microscopic inspection was performed that revealed the coil had jumped, which confirmed the reported event from the field.
Event or Problem Description
It was reported that coating issue occurred.The 99% stenosed target lesion was located in the mildly tortuous bile duct.A 035/145 (bx/5) amplatz super stiff guidewire was advanced for treatment.However, during the procedure, the coating was bulging or expanding slightly before the tip of the wire.The procedure was completed with another of the same device.There were no patient complications 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: 15327849
• Report Number: 2124215-2022-30418
• Device Sequence Number: 6484923
• Product Code: DQX
• UDI-Device Identifier: 08714729115809
• UDI-Public: 08714729115809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843016
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 02/20/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0028911166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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