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

Model Number	39695
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty occurred via attached voluntary medwatch report (b)(4).A 75cm.038 (bx/1) amplatz super stiff guidewire was selected for use.During the procedure, the wire was placed by physician to guide the non-boston scientific drain.However, upon removal of the guidewire, it was unable to be removed.The wire was removed together with the drain.No patient complications were reported.
Additional Manufacturer Narrative
Correction report filed to add the related record number of the medwatch form in block h10.
Event or Problem Description
It was reported that removal difficulty occurred via attached voluntary medwatch report (b)(4).A 75cm.038 (bx/1) amplatz super stiff guidewire was selected for use.During the procedure, the wire was placed by physician to guide the non-boston scientific drain.However, upon removal of the guidewire, it was unable to be removed.The wire was removed together with the drain.No patient complications were reported.

• 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: 19967291
• Report Number: 2124215-2024-46553
• Device Sequence Number: 21057363
• Product Code: DQX
• UDI-Device Identifier: 08714729295761
• UDI-Public: 08714729295761
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K843019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 03/23/2026
• Device Model Number: 39695
• Device Catalogue Number: 39695
• Device Lot Number: 0031303342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/04/2024
• Date Device Manufactured: 03/24/2023
• 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: 33 YR
• Patient Sex: Unknown