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

Model Number	39575
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the device would not retract and the wire coating noted to be separated.An amplatz super stiff guidewire was selected for use.During the procedure, the wire inadvertently exited through a side hole of the tube instead of the end hole and could not be retracted.The biliary tube showed no signs of encrustation or stickiness.A non bsc catheter was utilized to retrieve the wire.Upon examination, it was noted that the wire's coating or flat-wire coil had separated from the inner core of the wire.The procedure was completed and there were no patient complication as result of this event.
Event or Problem Description
It was reported that the device would not retract and the wire coating noted to be separated.An amplatz super stiff guidewire was selected for use.During the procedure, the wire inadvertently exited through a side hole of the tube instead of the end hole and could not be retracted.The biliary tube showed no signs of encrustation or stickiness.A non bsc catheter was utilized to retrieve the wire.Upon examination, it was noted that the wire's coating or flat-wire coil had separated from the inner core of the wire.The procedure was completed and there were no patient complication as result of this event.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.The device was returned for analysis and arrived in a generic plastic bag.An initial visual inspection did not reveal any obvious failures or evidence that may have been compromised due to the decontamination process.The device was then inspected following the peripheral intervention product analysis guidelines (bsc).Upon examination, it was determined that the guidewire had been returned, and it was observed that the coil wire had unraveled because the core wire was detached, separating from the distal tip up to the transition point.A photograph attached to the parent record confirms this observation, clearly showing the amplatz device with the unraveled coil wire resulting from the detachment of the core wire from the distal tip to the transition point.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21865733
• Report Number: 2124215-2025-23269
• Device Sequence Number: 4719205
• Product Code: DQX
• UDI-Device Identifier: 08714729115946
• UDI-Public: (01)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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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 Model Number: 39575
• Device Catalogue Number: 39575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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