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

Model Number	39575
Medical Device Problem Codes	Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the guidewire was returned for analysis.Visual inspection was performed which revealed the guidewire was bent and stretched at the distal tip section.Additionally, the core wire was exposed due to core wire separation from the bald solder.Based on analysis of the returned device, the reported guidewire stretching was confirmed.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2024.It was reported that guidewire stretched occurred.An amplatz super stiff guidewire was selected for use.Upon unpacking, it was found that the guidewire was stretched and could not be used normally.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed core wire separation from bald solder.

• 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: 19336866
• Report Number: 2124215-2024-29712
• Device Sequence Number: 6519155
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: 05/14/2026
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0031624517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 68 KG