MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83786
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that a protruding coil was removed with an additional device.An interlock-35 embolic coil was selected for use.The coil was deployed; however, it was protruding from the target location.Imaging revealed a residual 'thread' in the renal vein.The coil was removed with a lasso.There were no patient complications reported.
Event or Problem Description
It was reported that a protruding coil was removed with an additional device.An interlock-35 embolic coil was selected for use.The coil was deployed; however, it was protruding from the target location.Imaging revealed a residual 'thread' in the renal vein.The coil was removed with a lasso.There were no patient complications reported.
Additional Manufacturer Narrative
E1 - initial reporter information: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device eval by mfr: the device was received and analysis completed on 15jul2024.Visual inspection revealed that only the main coil was returned.It was observed that the main coil was bent and stretched at the coil arm and primary coil section, also the arm coil was detached.Functional inspection could not be performed since only the main coil was returned.Dimensional inspection revealed no damage or irregularities.
Event or Problem Description
It was reported that a protruding coil was removed with an additional device.An interlock-35 embolic coil was selected for use.The coil was deployed; however, it was protruding from the target location.Imaging revealed a residual 'thread' in the renal vein.The coil was removed with a lasso.There were no patient complications reported.

• Brand Name: INTERLOCK-35
• 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: 19298419
• Report Number: 2124215-2024-28500
• Device Sequence Number: 5919722
• Product Code: KRD
• UDI-Device Identifier: 08714729793137
• UDI-Public: 08714729793137
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133208
• 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,Followup
• Report Date (Section B): 07/16/2024

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: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0033420666
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 07/15/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/14/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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: Required Intervention
• Patient Sex: Unknown