MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -14; WIRE, GUIDE, CATHETER

Model Number	81725
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire was fractured, remained inside patient and procedure was not completed.Last (b)(6)2022, the patient came to hospital with a disturbance of consciousness.A 300cmx10cm fathom 14 was used in an intracranial arterial thrombectomy.However, the guidewire was fractured when used for rapid exchange.Subsequently, the fractured part of the guidewire remained in a branch of the intracranial middle cerebral artery and the procedure was not completed due to this event.The patient was sent to the icu without pulling out the tube under general anesthesia.At present, the physician has not found a way to remove the remaining guidewire.The patient was in a coma after the procedure, suffered from white lungs, and was on a ventilator, all due to covid-19 infection.Currently, the patient is awake, is experiencing hemiplegia, and has been transferred to the general ward.It was indicated that the hospital was not able to provide the remaining product.
Additional Manufacturer Narrative
Initial reporter address 1 : (b)(6).
Additional Manufacturer Narrative
E1.Initial reporter address (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device was returned to this complaint, and it was observed that the guidewire was detached, and the coil wire was unraveled at the distal section.No more damages or issues were observed.Under the microscope it was observed that the guidewire was detached and unraveled at the distal section.
Event or Problem Description
It was reported that the guidewire was fractured, remained inside patient and procedure was not completed.Last december 31,2022, the patient came to hospital with a disturbance of consciousness.A 300cmx10cm fathom -14 was used in an intracranial arterial thrombectomy.However, the guidewire was fractured when used for rapid exchange.Subsequently, the fractured part of the guidewire remained in a branch of the intracranial middle cerebral artery and the procedure was not completed due to this event.The patient was sent to the icu without pulling out the tube under general anesthesia.At present, the physician has not found a way to remove the remaining guidewire.The patient was in a coma after the procedure, suffered from white lungs, and was on a ventilator, all due to covid-19 infection.Currently, the patient is awake, is experiencing hemiplegia, and has been transferred to the general ward.It was indicated that the hospital was not able to provide the remaining product.

• Brand Name: FATHOM -14
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16335994
• Report Number: 2124215-2023-01571
• Device Sequence Number: 12317317
• Product Code: DQX
• UDI-Device Identifier: 08714729801047
• UDI-Public: 08714729801047
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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 Expiration Date: 04/27/2025
• Device Model Number: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0029307946
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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: Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Male