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

Model Number	39575
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).
Event or Problem Description
It was reported that guidewire tip was stretched and stuck occurred.An amplatz super stiff guidewire was selected for use along with a non-boston scientific thrombectomy system.During the second thrombectomy procedure, it was noted that the tip of the wire was stretched when trying to pass the catheter for the second time.The wire became stuck with the catheter and was not moving.Both the wire and thrombectomy device were removed together as it could not be detached from one another.The procedure was completed.No patient complications were reported.
Event or Problem Description
It was reported that guidewire tip was stretched and stuck occurred.An amplatz super stiff guidewire was selected for use along with a non-boston scientific thrombectomy system.During the second thrombectomy procedure, it was noted that the tip of the wire was stretched when trying to pass the catheter for the second time.The wire became stuck with the catheter and was not moving.Both the wire and thrombectomy device were removed together as it could not be detached from one another.The procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).Device evaluated by mfr: the guidewire was returned, and it was observed that the coil wire was unraveled.The core wire was found detached and separated from distal tip to the transition point.Also, the guidewire was kinked and bent at distal section.

• 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: 19370851
• Report Number: 2124215-2024-31006
• Device Sequence Number: 7703750
• Product Code: DQX
• UDI-Device Identifier: 08714729295747
• UDI-Public: 08714729295747
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K843015
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 10/20/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0030395455
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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