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

Model Number	83785
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a retained material was identified inside the patient's body.The patient underwent left gonadal vein embolization using a 177cm coil pusher-16 coil.During the procedure, the coil did not deploy as usual, requiring the physician to manipulate the coil to complete the deployment.At the time, there was no indication that the device was damaged or that the patient retained any material.The procedure was completed as intended, and the device was discarded after the procedure as per the usual process.The patient had an uneventful recovery and was discharged the same day.However, three months following the embolization procedure, the patient had a computed tomography (ct) scan at a private radiology service.It was noted that a retained material had been identified, which was likely from the embolization procedure.The patient is currently seeking medical advice regarding the retained material.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20727820
• Report Number: 2124215-2024-69748
• Device Sequence Number: 12997137
• Product Code: KRD
• UDI-Device Identifier: 08714729158967
• UDI-Public: 08714729158967
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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
• Device Lot Number: 0032875817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/19/2024
• Date Device Manufactured: 11/17/2023
• 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
• Patient Sex: Unknown