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

Model Number	M001363820
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial healthcare facility - (b)(6).
Event or Problem Description
It was reported that the device was separated.A 15mm x 40cm interlock-35 was selected for use during an embolization procedure.During the procedure, while attempting to deploy the coils, it was noted that a separation occurred.The coil was removed, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that during deployment, the coil remained attached to its pusher and did not detach.Upon attempting to remove the device, the coil began to unravel, causing it to elongate.It was noted that the coil had unraveled to the point that when the main device was removed, they had to continue pulling out the unraveled portion until it was all out of the body.There was not a separate section that had to be removed separately.
Event or Problem Description
It was reported that the device was separated.A 15 mm x 40 cm interlock-35 was selected for use during an embolization procedure.During the procedure, while attempting to deploy the coils, it was noted that a separation occurred.The coil was removed and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial healthcare facility: (b)(6).We completed a good faith effort to obtain additional event detail information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the device was separated.A 15 mm x 40 cm interlock-35 was selected for use during an embolization procedure.During the procedure, while attempting to deploy the coils, it was noted that a separation occurred.The coil was removed, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that during deployment, the coil remained attached to its pusher and did not detach.Upon attempting to remove the device, the coil began to unravel, causing it to elongate.It was noted that the coil had unraveled to the point that when the main device was removed, they had to continue pulling out the unraveled portion until it was all out of the body.There was not a separate section that had to be removed separately.
Additional Manufacturer Narrative
E1: initial healthcare facility: (b)(6).Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, only the main coil was returned.Upon visual and microscopic inspection, the main coil was bent and stretched in both the coil arm and primary coil sections.The clinical observations were confirmed.

• 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: 21691723
• Report Number: 2124215-2025-16440
• Device Sequence Number: 15773448
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: (01)08714729795438(17)270531(10)34143517
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2025

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: M001363820
• Device Catalogue Number: M001363820
• Device Lot Number: 0034143517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 05/29/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/23/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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 Sex: Unknown