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

Model Number	83787
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device fracture occurred.Two 15mm x 40cm interlock-35 coils were selected for use in an embolization procedure located in the abdominal aortic aneurysm and the internal iliac artery.During the procedure, when placing the first coil, it was found that the coil could not be pushed out of the delivery catheter, and two positions of the interlocking arm were fractured.This coil was removed, and exchanged for a new coil, same model.The second coil was advanced.Half of it was released into the aneurysm cavity.However, the position was not proper, so it was withdrawn.When the tip of the coil was withdrawn nearly to the angiography catheter, it could not be withdrawn, and the interlocking arm connection was found to be fractured.The coil was removed along with the angiography catheter, and the procedure was completed with another of the same device.No patient complications were reported, and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: no.(b)(6).Device eval by mfr: the device was not returned.However, a photo was provided from the healthcare facility.It shows that the device stretched, and it did not show any fracture or break.Therefore, the reported allegations could not be confirmed.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that a device fracture occurred.Two 15mm x 40cm interlock-35 coils were selected for use in an embolization procedure located in the abdominal aortic aneurysm and the internal iliac artery.During the procedure, when placing the first coil, it was found that the coil could not be pushed out of the delivery catheter, and two positions of the interlocking arm were fractured.This coil was removed, and exchanged for a new coil, same model.The second coil was advanced.Half of it was released into the aneurysm cavity.However, the position was not proper, so it was withdrawn.When the tip of the coil was withdrawn nearly to the angiography catheter, it could not be withdrawn, and the interlocking arm connection was found to be fractured.The coil was removed along with the angiography catheter, and the procedure was completed with another of the same device.No patient complications were reported, and the patient was stable post-procedure.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the main coil, the introducer sheath and the delivery wire were returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, and it was observed that the main coil was bent and stretched at the coil arm and primary coil section.Dimensional inspection of the main coil revealed the components were within specifications.A picture was received in the event; however, the picture shows the device stretched but it did not show any fracture or break.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a device fracture occurred.Two 15mm x 40cm interlock-35 coils were selected for use in an embolization procedure located in the abdominal aortic aneurysm and the internal iliac artery.During the procedure, when placing the first coil, it was found that the coil could not be pushed out of the delivery catheter, and two positions of the interlocking arm were fractured.This coil was removed, and exchanged for a new coil, same model.The second coil was advanced.Half of it was released into the aneurysm cavity.However, the position was not proper, so it was withdrawn.When the tip of the coil was withdrawn nearly to the angiography catheter, it could not be withdrawn, and the interlocking arm connection was found to be fractured.The coil was removed along with the angiography catheter, and the procedure was completed with another of the same device.No patient complications were reported, and the patient was stable post-procedure.

• 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: 19883759
• Report Number: 2124215-2024-46959
• Device Sequence Number: 19870806
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: 08714729795438
• 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,Followup
• Report Date (Section B): 04/24/2025

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 Expiration Date: 09/18/2026
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0032456770
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 08/12/2024; 04/01/2025
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/04/2024; 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 76 KG