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

Model Number	83787
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 06nov2024.It was reported that premature deployment occurred.A 10mm x 40cm interlock-35 cube coil was advanced for partial splenic artery embolization.During the procedure, the locking arm was released prematurely in the renegade stc-35 microcatheter and could not be advanced forward.The physician removed the delivery system together with the coil.The procedure was completed with a different device.No complications were reported, and the patient condition following procedure was stable.However, returned device analysis revealed the coil arm was detached.
Additional Manufacturer Narrative
A2 age at time of event: 18 years or under.E1 initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection observed that the main coil, the introducer sheath, and the delivery wire were returned.The main coil was bent and stretched at the coil arm section.Moreover, the coil arm was detached.Additionally, the introducer sheath was detached at the twist lock section.Functional inspection could not be performed as the main coil and the pusher wire were not interlocking.

• 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: 20847002
• Report Number: 2124215-2024-72923
• Device Sequence Number: 12772517
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: 08714729795513
• 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): 12/04/2024

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: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0032997542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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: MICROCATHETER: RENEGADE STC-35
• Patient Sex: Male