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

Model Number	39695
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties occurred.The patient was being treated with abdominal abscess.The stenosed target lesion was located in the non-tortuous and non-calcified left renal artery.A 75cm.035 (bx/5) amplatz super stiff guidewire was inserted.However, the wire was trapped within the non-boston scientific drainage device while trying to remove.The device and drain removed together and the procedure restarted and completed with different wire.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.Unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire was returned for the analysis; it was observed that the coil wire was unraveled, and the guidewire was bent at the distal section.No more damages were observed.
Event or Problem Description
It was reported that there was a difficulty in removing the device occurred.The patient is treated with abdominal abscess.The stenosed target lesion was located in the not tortuous and not calcified left kidney artery.A ss 75cm.035 (bx/5) amplatz super stiff guidewire was inserted.However, when they are pulling wire got struck while trying to remove, they had difficulty removing it.Physician was able to remove the device, and the procedure was completed successfully but had to start from the beginning.There were no patient complications nor injuries 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: 16996348
• Report Number: 2124215-2023-22806
• Device Sequence Number: 6965481
• Product Code: DQX
• UDI-Device Identifier: 08714729114604
• UDI-Public: 08714729114604
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K843018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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: 01/05/2026
• Device Model Number: 39695
• Device Catalogue Number: 39695
• Device Lot Number: 0030804242
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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 Sex: Unknown