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

Model Number	M001363830
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name - (b)(6).The device was returned for analysis.Media review of a picture provided by the customer revealed the main coil and the pouch information.It was observed that the main coil was stretched, kink and detached at the coil arm section.Additionally, the pouch information matches with upn provided by the customer.Visual and microscopic inspection revealed the main coil was kink at the zap tip section, and it was bent, stretched and detached at the coil arm section.Measurements of the main coil dimensions were within specification.
Event or Problem Description
Reportable based on the device analysis completed 22jul2025.It was reported that the coil could not be withdrawn from the catheter.The target lesion was located in the abdominal aorta.A 20mm x 40cm interlock.035 was selected for use.During the procedure, a non-boston scientific 5f catheter was used for the internal iliac artery embolization.The first 20 x 40 controllable coil was deployed with poor positioning and could not be withdrawn.After removing the contrast catheter, a replacement coil was successfully deployed.Similarly, during the second 20 x 40 coil deployment, unloading occurred.After withdrawing the contrast catheter, a another of the same coil was successfully deployed.There were no patient complications as a result of this event and the patient status was stable.However, returned device analysis revealed a detachment at the coil arm section.

• 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: 22829129
• Report Number: 2124215-2025-56154
• Device Sequence Number: 19974592
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: (01)08714729795445(17)260731(10)32130417
• 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
• Report Date (Section B): 08/18/2025

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: 07/31/2026
• Device Model Number: M001363830
• Device Catalogue Number: M001363830
• Device Lot Number: 0032130417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER: CORDIS MPA 5F 100
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 74 KG