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

Model Number	39575
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire coating peeled.An amplatz pi guidewire was selected for use in a biliary stenting procedure.A biliary stent was successfully placed in the left bile duct.After placement of the stent, the amplatz was removed.During removal the wire coating peeled from the wire.Some fragments of the coating could have remained attached to the implanted biliary stent.The procedure was completed with the original devices.There were no patient complications.
Additional Manufacturer Narrative
Evaluation by manufacturer: the unit was returned with its original pouch batch (b)(6).Overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was inspected according to the procedure.The guidewire was returned, and it was observed that the core wire was detached at 2.5 cm from distal tip, and the coil wire was unraveled.The pouch was returned, and it was observed that the pouch information matches with the complaint information.Under microscope, it was observed that the core wire was detached at 2.5 cm from distal tip, and the core wire was unraveled.
Event or Problem Description
It was reported that the guidewire coating peeled.An amplatz super stiff guidewire was selected for use in a biliary stenting procedure.A biliary stent was successfully placed in the left bile duct.After placement of the stent, the amplatz was removed.During removal the coating peeled from the guidewire.Some fragments of the coating could have remained attached to the implanted biliary stent.The procedure was completed with the original devices.There were no patient complications.

• 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: 16014107
• Report Number: 2124215-2022-53178
• Device Sequence Number: 17735228
• Product Code: DQX
• UDI-Device Identifier: 08714729295723
• UDI-Public: 08714729295723
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0029462719
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown