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

Model Number	39575
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: discrepancy in aware date and event date.Boston scientific aware date provided was 10jul2020.The date of the procedure provided was (b)(6) 2020.
Event or Problem Description
It was reported that tip detachment occurred.An amplatz super stiff guidewire was selected for use in a procedure and during the procedure, the tip detached from the wire while inside the patient.The device was removed from the patient.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event: additional information confirmed date of event to be (b)(6) 2020.B5: describe event or problem - updated.
Event or Problem Description
It was reported that tip detachment occurred.An amplatz super stiff guidewire was selected for use in a procedure and during the procedure, the tip detached from the wire while inside the patient.The device was removed from the patient.No patient complications were reported.It was further reported that the guidewire was used in an aortic stent graft procedure and the lesion was not calcified.The tip of the wire was retrieved using a snare.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10370252
• Report Number: 2134265-2020-10396
• Device Sequence Number: 16875615
• Product Code: DQX
• UDI-Device Identifier: 08714729295730
• UDI-Public: 08714729295730
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K843013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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: 02/05/2023
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0025169804
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention