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

Model Number	M001363630
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.E1 initial reporter facility name: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection observed that only the main coil was returned.The main coil was bent and stretched at the coil arm and primary coil section, moreover the arm coil was detached.Functional inspection could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection was performed, and the main coil's zap tip outer diameter (od) and primary coil od passed the specification test.The customer used a non-boston scientific diagnostic catheter.Other diagnostic catheters may result in an inability to deliver, deploy, or recapture the device.The stretched coil arm found during the product inspection, could have contributed to the reported issue.
Event or Problem Description
Reportable based on device analysis completed on 12dec2024.It was reported that coil became stuck during delivery.The patient underwent internal iliac aneurysm procedure.A 12mm x 40cm interlock-35 coil was selected for embolization.The physician used a 7f non-boston scientific long sheath to cross and an imaging catheter; however, the coil could not be delivered, it became stuck.The angle was adjusted many times but failed.The coil was then removed and found it was stretched.The procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.However, returned 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: 21048725
• Report Number: 2124215-2024-81840
• Device Sequence Number: 14305173
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: 08714729792970
• 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): 12/31/2024

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 Expiration Date: 07/25/2026
• Device Model Number: M001363630
• Device Catalogue Number: M001363630
• Device Lot Number: 0032089438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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: IMAGING CATHETER: APT; SHEATH: 7F COOK
• Patient Sex: Male