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

Model Number	39575
Medical Device Problem Codes	Unraveled Material (1664); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned to the manufacturer: the amplatz wire underwent a product analysis, and it was observed that the core wire was found detached/separated from the distal tip to the bald weld.In addition, the guidewire was bent in the distal section.Consequently, the reported events of difficult to cross and unraveled material were confirmed due to the device's condition.E1: initial reporter address 2: 50m east of huimin lane and its entrance.
Event or Problem Description
Reportable based on device analysis completed on 11jan2024.The stenosed target lesion was located in the left iliac artery where the patient underwent a balloon dilation and stent implantation.The patient was supine during the procedure and their right femoral was punctured where a 6-french sheath was used for the puncture followed by a non-boston scientific 7-french sheath.An xch/035/260 (bx/5) amplatz guidewire was advanced, and it entered the artery.There was difficulty in moving forward or back and it failed to cross the lesion after several attempts.The device was removed from the patient and discovered to be badly stretched.The procedure was completed with another of the same model where the patient status was in a stable condition.No complications were reported.However, when the device was returned for an analysis, it revealed that the core wire was found detached/separated from the distal tip of the bald weld.In addition, the guidewire was bent in the 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: 18647234
• Report Number: 2124215-2024-05787
• Device Sequence Number: 15504108
• Product Code: DQX
• UDI-Device Identifier: 08714729115830
• UDI-Public: 08714729115830
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K843016
• 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
• Report Date (Section B): 02/05/2024

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: 04/25/2026
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0031505007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 65 KG