MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COIL PUSHER-16; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83785
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that coil pusher break occurred, and a fragment remained inside the patient, requiring additional intervention.A 177 cm coil pusher-16 was selected for use to push the unknown coil through the catheter.During removal, there was resistance in retracting and when removed, it was noticed that a fragment from the end of the pusher had snapped off and dislodged in the patient.The device fragment was caged with coils to avoid migration.There were no patient complications reported.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 08/01/2024 as the exact event date was not reported.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 08/01/2024 as the exact event date was not reported.
Event or Problem Description
It was reported that coil pusher break occurred, and a fragment remained inside the patient, requiring additional intervention.A 177 cm coil pusher-16 was selected for use to push the unknown coil through the catheter.During removal, there was resistance in retracting and when removed, it was noticed that a fragment from the end of the pusher had snapped off and dislodged in the patient.The device fragment was caged with coils to avoid migration.There were no patient complications reported.It was further reported that the target lesion was located in the left gonadal (testicular) vein.The fragment was retained in the same vein (left gonadal vein) that was embolized as planned using non-boston scientific coils.

• Brand Name: COIL PUSHER-16
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19986714
• Report Number: 2124215-2024-49363
• Device Sequence Number: 12527891
• Product Code: KRD
• UDI-Device Identifier: 08714729158967
• UDI-Public: 08714729158967
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 83785
• Device Catalogue Number: 83785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/11/2024
• 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: Other; Required Intervention
• Patient Sex: Unknown