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

Model Number	39575
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a foreign material was found on the device.A 035/260 amplatz super stiff guidewire was selected for use.However, during preparation, a foreign matter was found in individual product bag.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that a foreign material was found on the device.A 035/260 amplatz super stiff guidewire was selected for use.However, during preparation, a foreign matter was found in individual product bag.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
The device was inspected according to procedure.The device returned inside the pouch, and it was observed that the pouch information matches with the complaint information.The pouch was closed, and no open section was identified, however, a foreign matter was observed inside the package.There are none visual defects, contamination or damages observed on the pouch.The foreign matter was measured with the size estimation chart.According to the procedure, the foreign matter does not exceed the maximum size allowed.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16577164
• Report Number: 2124215-2023-09787
• Device Sequence Number: 4697149
• Product Code: DQX
• UDI-Device Identifier: 08714729115830
• UDI-Public: 08714729115830
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: 12/15/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0030728056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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