MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IDC?; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M0013614080
Medical Device Problem Codes	Break (1069); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Foreign Body In Patient (2687)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter phone- (b)(6).Detailed product information was not provided to bsc as the account did not have the available information.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.
Event or Problem Description
It was reported that the coil unraveled and protruded from the target location, requiring additional intervention.An idc 18 soft coil 4mm x 8cm was selected for a varicoele embolization procedure.The idc 18 soft coil 4mm x 8cm was implanted in addition to multiple other embolic coils.When deploying this coil, however, there were slight issues during deployment, and the coil was re-sheathed as it didn't deploy correctly.The original device was used to complete the procedure.Overnight, the patient experienced pain and discomfort and noticed a coil protruding out of an open-wound scalpel incision in their groin.A complex extraction was planned for the next day.At the time of presentation, it seemed the coil was sandwiched between several other coils used during varicocoele embolisation.Therefore, simply pulling it was not feasible as this risked dislodging proximal coils.Instead, it was approached from the neck and groin at the same time, and they were able to snap the coil in the renal vein.During the extraction, the coil was half-removed, with a small amount left within the renal vein.No coil was left in the inferior vena cava (ivc) or right common iliac vein (rciv).

• Brand Name: IDC?
• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24323196
• Report Number: 2124215-2026-07525
• Device Sequence Number: 9674664
• Product Code: KRD
• UDI-Device Identifier: 08714729158745
• UDI-Public: (01)08714729158745
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141378
• 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
• Report Date (Section B): 02/12/2026

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: M0013614080
• Device Catalogue Number: M0013614080
• 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: 01/14/2026
• Initial Report FDA Received Date: 02/12/2026
• 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
• Patient Sex: Unknown