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

Model Number	39615
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Intracranial Hemorrhage (1891); Respiratory Failure (2484)
Date of Event	11/07/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died via attached voluntary medwatch report #mw5175144.The patient was transferred on (b)(6) after presenting with stroke symptoms.The patient became bradycardic, and their national institutes of health (nih) stroke scale score worsened.A repeat ct revealed a new intracerebral hemorrhage, prompting administration of tranexamic acid (txa) and was transferred to another facility on (b)(6).Upon arrival, fibrinogen levels were 241, and no further txa was given.Blood pressure was managed with nicardipine, and clopidogrel was started.The patient remained communicative until respiratory failure developed on (b)(6), requiring intubation on (b)(6).Despite efforts to improve their condition, they failed spontaneous breathing trials and declined a tracheostomy.Terminal extubation was performed on (b)(6), and the patient passed away shortly after.Additional information has been requested regarding the details leading up to this event.
Additional Manufacturer Narrative
B2: updated outcomes attrib to adv event.B2: updated date of death.
Event or Problem Description
It was reported that the patient died via attached voluntary medwatch report #mw5175144.The patient was transferred on (b)(6) after presenting with stroke symptoms.The patient became bradycardic, and their national institutes of health (nih) stroke scale score worsened.A repeat ct revealed a new intracerebral hemorrhage, prompting administration of tranexamic acid (txa) and was transferred to another facility on (b)(6).Upon arrival, fibrinogen levels were 241, and no further txa was given.Blood pressure was managed with nicardipine, and clopidogrel was started.The patient remained communicative until respiratory failure developed on (b)(6), requiring intubation on (b)(6).Despite efforts to improve their condition, they failed spontaneous breathing trials and declined a tracheostomy.Terminal extubation was performed on (b)(6), and the patient passed away shortly after.Additional information has been requested regarding the details leading up to this event.It was further reported that the patient received tenecteplase prior to transfer, and within 8 hours of administration.

• 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: 23157552
• Report Number: 2124215-2025-67135
• Device Sequence Number: 10102282
• Product Code: DQX
• UDI-Device Identifier: 08714729295648
• UDI-Public: (01)08714729295648(17)280511(10)36501107
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K843012
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0036501107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 05/12/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR
• Patient Sex: Female