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

Model Number	39575
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	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via user facility medwatch # (b)(4) that guidewire detachment occurred.The patient presented with gallstones and underwent a chole tube and biliary drain exchange procedure.The target lesion was located in the biliary tube.A 035/145 amplatz super stiff guidewire was advanced and placed in the existing tube, tube was removed, and a new tube was placed.Physician noticed wire was unraveling so he added a non- boston scientific (bsc) wire to amplatz wire to maintain access.The physician removed the tube and no issues with tube.The physician then carefully removed wire successfully but was concerned because the wire continued to unravel during removal.However, during the procedure the amplatz wire sheared off in the biliary tube and became stuck in the patient's duodenum.All components were successfully removed and the procedure was completed with a non-bsc device.No patient complications nor injuries reported and the patient status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: unit returned with its original pouch; the unit returned split in two pieces.The device was inspected according to procedure.The customer attached a fluoroscopy pictures, nevertheless as per pictures provided, no damages were observed at the part of the device taken at the pictures.The guidewire was returned, and it was observed that the coil wire was detached and unraveled, also the core wire was detached at 2.4 cm from the distal tip.Under microscope it was observed that the core wire was detached.
Event or Problem Description
It was reported via user facility medwatch # (b)(4) that guidewire detachment occurred.The patient presented with gallstones and underwent a chole tube and biliary drain exchange procedure.The target lesion was located in the not calcified biliary tube.A 035/145 amplatz super stiff guidewire was advanced and placed in the existing tube, tube was removed, and a new tube was placed.Physician noticed wire was unraveling so he added a non- boston scientific (bsc) wire to amplatz wire to maintain access.The physician slowly removed the tube and no issues with tube.The physician then carefully removed wire successfully but was concerned because the wire continued to unravel during removal.However, during the procedure the amplatz wire sheared off in the biliary tube and became stuck in the patient's duodenum.All components were successfully removed, and the procedure was completed with a non-bsc device.No patient complications nor injuries reported, and the patient status was fine.

• 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: 16138485
• Report Number: 2124215-2022-55252
• Device Sequence Number: 12429608
• Product Code: DQX
• UDI-Device Identifier: 08714729115946
• UDI-Public: 08714729115946
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 06/06/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0029543100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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 Age: 84 YR
• Patient Sex: Unknown