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

Model Number	83786
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2024.It was reported that coil detachment occurred.The patient was in a supine position and underwent a left renal artery aneurysm procedure located in the right femoral artery.The artery was punctured with a micro-puncture needle inserted into a 4f short sheath.The catheter was inserted into the abdominal aorta at the 12th thoracic vertebra level.A non-boston scientific catheter was used to check on the left renal artery opening where the guidewire was followed into the distal end.A single curved catheter and hydrophobic-coated guidewire were replaced.The guidewire and the tip of the catheter were inserted into the aneurysm body and the catheter position was confirmed by hand angioplasty.A 6mm x 10cmm, 4mm x 15cm, 4mm x 10cm, and 5mm x 15cm interlock-35 coils were sent for deployment.During the procedure, the 4mm x 10cm coil was released inside the catheter.The physician replaced it with a 6mm x 10cm coil.The embolization process was smooth and successful.After the procedure, the aneurysm was confirmed by angiography to have disappeared.There were no complications reported, and patient was returned to the ward safely.However, returned device analysis revealed a detached coil at the arm section.
Additional Manufacturer Narrative
E1 - intial reporter facility name: (b)(6) university.Device evaluated by mfr.: device was returned for analysis.Visual inspection revealed the main coil was bent and stretched at the coil arm, primary coil and zap tip section, also was detached at middle section, moreover the arm coil and the zap tip were detached.The functional inspection could not be performed due only the main coil was returned.The outer diameter (od) of the main coil and primary coil od passed the dimensional inspection.

• 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: 19499869
• Report Number: 2124215-2024-34169
• Device Sequence Number: 7907561
• Product Code: KRD
• UDI-Device Identifier: 08714729792987
• UDI-Public: 08714729792987
• 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): 06/10/2024

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: 05/17/2026
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0031645380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 60 KG