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

Model Number	83779
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that the coil could not advance.A 6mm x 10cm f-idc 2d coil was selected for pulmonary collateral embolization.During the procedure, the coil was advanced inside the boston scientific microcatheter, but it was noted that the target lesion was not ideal.Therefore, the device was adjusted.However, it got stuck inside the microcatheter and could not be pushed out.The coil was removed together with the catheter as it could not be delivered after multiple attempts.The procedure was completed with a new microcatheter and another of the same coil.No complications were reported, and the patient was stable.However, returned device analysis revealed a detached coil at the arm section.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis, and the pouch information matches the complaint information.Visual and microscopic inspection of the main coil, the pusher wire, introducer sheath was performed, and revealed that the main coil was bent, stretched at the zap tip section, and detached at the coil arm section.Functional inspection could not be performed, because the delivery wire and the main coil are not interlocking.Dimensional inspection of the outer diameter of zap tip and primary coil were within specification.

• Brand Name: INTERLOCK
• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17607289
• Report Number: 2124215-2023-44746
• Device Sequence Number: 12302505
• Product Code: KRD
• UDI-Device Identifier: 08714729764991
• UDI-Public: 08714729764991
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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
• Report Date (Section B): 08/23/2023

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: 07/24/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030017206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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: 5 YR
• Patient Sex: Male
• Patient Weight: 20 KG