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

Model Number	M001363820
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coil break occurred.The target lesion was located in a non-tortuous iliaca interna.A.035 interlock cube 15mm x 40cm was selected to treat an iliaca interna aneurysm.During the procedure, the coil was pushed about halfway out of the diagnostic catheter, then an attempt was made to pull the coil back again to reposition the catheter.The coil got stuck in the catheter as it was already partially thrombogenized.The physician then pulled a little too tightly, causing the coil to stretch and the detachment arm to detach from the coil.The diagnostic catheter with complete coil was removed from the patient.A new catheter and coil were successfully used.No patient harm occurred.
Event or Problem Description
It was reported that a coil break occurred.The target lesion was located in a non-tortuous iliaca interna.A.035 interlock cube 15mm x 40cm was selected to treat an iliaca interna aneurysm.During the procedure, the coil was pushed about halfway out of the diagnostic catheter, then an attempt was made to pull the coil back again to reposition the catheter.The coil got stuck in the catheter as it was already partially thrombogenized.The physician then pulled a little too tightly, causing the coil to stretch and the detachment arm to detach from the coil.The diagnostic catheter with complete coil was removed from the patient.A new catheter and coil were successfully used.No patient harm occurred.It was further reported that there was no break observed, rather the interlocking arms unlocked inside of the diagnostic catheter.The pusher wire of the interlock was pulled completely out of the catheter while the coil remained in the catheter.
Event or Problem Description
It was reported that a coil break occurred.The target lesion was located in a non-tortuous iliaca interna.A.035 interlock cube 15mm x 40cm was selected to treat an iliaca interna aneurysm.During the procedure, the coil was pushed about halfway out of the diagnostic catheter, then an attempt was made to pull the coil back again to reposition the catheter.The coil got stuck in the catheter as it was already partially thrombogenized.The physician then pulled a little too tightly, causing the coil to stretch and the detachment arm to detach from the coil.The diagnostic catheter with complete coil was removed from the patient.A new catheter and coil were successfully used.No patient harm occurred.It was further reported that there was no break observed, rather the interlocking arms unlocked inside of the diagnostic catheter.The pusher wire of the interlock was pulled completely out of the catheter while the coil remained in the catheter.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the main coil, the introducer sheath and the delivery wire were returned.It was observed that the main coil was bent and stretched at the coil arm and primary coil section, moreover the arm coil was detached.A photo provided by the site shows the device stretched.

• 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: 20790347
• Report Number: 2124215-2024-74630
• Device Sequence Number: 12509931
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: 08714729795438
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2025

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: 0033469143
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 12/02/2024; 03/05/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/09/2024; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DIAGNOSTIC CATHETER- IMAGER; DIAGNOSTIC CATHETER- IMAGER; DIAGNOSTIC CATHETER- IMAGER
• Patient Sex: Unknown