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

Model Number	M001363590
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: only the main coil was returned was returned to our post market quality assurance laboratory.Visual inspection was performed and it was observed that the main coil was bent and stretched at the primary coil section, moreover the arm coil was detached.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 21aug2025.It was reported that the coil could not be pushed out of the sheath.The patient presented with splenic aneurysm underwent embolization using an 8mm x 40cm interlock.035 coil.During the procedure, the guide wire was used to go up from the right iliac artery puncture site to the opening of the splenic aneurysm lesion.After the guide wire was in place, a non-boston scientific angiography catheter was used to reach the embolization site.However, when the coil was advanced while flushing, the coil could not be pushed out of the sheath.The physician tried several times, but it could not push the coil out.The procedure was completed using a 0.35 system 10mm x 40cm interlock coil.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed the arm coil was detached.
Additional Manufacturer Narrative
Device evaluated by mfr: only the main coil was returned was returned to our post market quality assurance laboratory.Visual inspection was performed and it was observed that the main coil was bent and stretched at the primary coil section, moreover the arm coil was detached.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 21aug2025.It was reported that the coil could not be pushed out of the sheath.The patient presented with splenic aneurysm underwent embolization using an 8mm x 40cm interlock.035 coil.During the procedure, the guide wire was used to go up from the right iliac artery puncture site to the opening of the splenic aneurysm lesion.After the guide wire was in place, a non-boston scientific angiography catheter was used to reach the embolization site.However, when the coil was advanced while flushing, the coil could not be pushed out of the sheath.The physician tried several times, but it could not push the coil out.The procedure was completed using a 0.35 system 10mm x 40cm interlock coil.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed the arm coil was detached.

• 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: 23080126
• Report Number: 2124215-2025-64499
• Device Sequence Number: 14649069
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: (01)08714729793014(17)271015(10)35066540
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001363590
• Device Catalogue Number: M001363590
• Device Lot Number: 0035066540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 74 KG