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

Model Number	39695
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event : 18 years or older.Date of event: event date was not reported and was approximated to (b)(6) 2021.
Event or Problem Description
It was reported that the device was difficult to remove.A 75cm amplatz super stiff guidewire was selected for use in a drainage procedure.Upon removal from packaging, the device looked whole and was flushed with saline.During the procedure, the device was used in the kidney.Prior to removing the device, the physician noted that the tip was broken into small threads.It was difficult to pull the device out, but it was removed.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that the device was difficult to remove.A 75cm amplatz super stiff guidewire was selected for use in a drainage procedure.Upon removal from packaging, the device looked whole and was flushed with saline.During the procedure, the device was used in the kidney.Prior to removing the device, the physician noted that the tip was broken into small threads.It was difficult to pull the device out, but it was removed.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
A2: age at time of event - 18 years or older.B3: date of event - event date was not reported and was approximated to (b)(6) 2021.Device evaluated by manufacturer.Device was inspected visually and it was noted that the returned guidewire was stretched and unraveled at the distal end.Additionally, the wire was detached at the distal end.It was observed microscopically that the core wire was detached at the distal end.Dimensional inspection revealed the overall length and distal tip length measurements showed the guidewire stretched, however the middle section and proximal section were within specification.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11773542
• Report Number: 2134265-2021-05163
• Device Sequence Number: 14242392
• Product Code: DQX
• UDI-Device Identifier: 08714729114604
• UDI-Public: 08714729114604
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 01/15/2024
• Device Model Number: 39695
• Device Catalogue Number: 39695
• Device Lot Number: 0026641472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1