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

Model Number	39695
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2021 since none was provided.
Event or Problem Description
It was reported that guidewire removal difficulty occurred.A 75cm.035 amplatz super stiff guidewire was used for a port placement procedure.During the procedure, the guidewire became lodged in the patient's coronary.The physician was able to withdrawal the wire however the tip became unraveled.The physician was able to pull the wire out completely and feels the patient is recovering well.
Additional Manufacturer Narrative
(b3) date of event: updated from (b)(6) 2021 to (b)(6) 2021 as per additional information.
Event or Problem Description
It was reported that guidewire removal difficulty occurred.A 75cm.035 amplatz super stiff guidewire was used for a port placement procedure.During the procedure, the guidewire became lodged in the patient's coronary.The physician was able to withdrawal the wire however the tip became unraveled.The physician was able to pull the wire out completely and feels the patient is recovering well.It was further reported that the difficulty in removing the amplatz super stiff guidewire from the patient was due to the device being lodged in the patient's coronary.The procedure was completed with a different device and the patient's status was stable.

• 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: 11569268
• Report Number: 2134265-2021-03789
• Device Sequence Number: 17043687
• Product Code: DQX
• UDI-Device Identifier: 08714729295754
• UDI-Public: 08714729295754
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K843017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 12/05/2023
• Device Model Number: 39695
• Device Catalogue Number: 39695
• Device Lot Number: 0026469851
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1